News | Intra-Aortic Balloon Pumps (IABP) | November 05, 2018

Maquet/Datascope Intra-Aortic Balloon Pumps Might Fail on Battery Power

Vendor issues letter to healthcare providers warning of 75 cases of device shut down

he U.S. Food and Drug Administration (FDA) is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power.

November 5, 2018 — The U.S. Food and Drug Administration (FDA) is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power. The company issued a letter to providers warning them about this issue Nov. 1, 2018. 

IABPs are used on critically-ill patients in health care facilities, including during transport. The vendor said an interruption in treatment can result in serious patient injury or death.

The Maquet/Datascope IABP is a cardiac assist device placed in the descending aorta, just distal to the left subclavian artery. The device is an electromechanical system used to inflate and deflate intra-aortic balloons, which provides temporary support to the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Getinge manufactures the following Maquet/Datascope IABP devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i.

Since 2017, the FDA has received more than 75 medical device reports of Maquet/Datascope IABP devices shutting down while running on battery, leading to pump stop and loss of hemodynamic support. Five of these reports described three patient deaths, although the deaths cannot be definitively attributed to the device shutting down. Other reports describe serious patient injury such as a sudden drop in blood pressure or the need for resuscitation. At least six reports indicated that there was no alarm warning before the device shutdown.

The company said the onset of the shutdown as described in the reports ranges from immediately following disconnection of the IABP from AC power (electricity) to within the expected battery run time.

In addition to device shutdown, there are reports describing several battery issues that could lead to patient harm, such as the device not charging the battery, the battery charge indicator not working properly or not showing the correct status of the battery charge, or the battery depleting sooner than expected.

"At this time, the root cause or incidence rate of these IABP devices shutting down while on batteries is not known. Although we are concerned about the device shutdown events associated with Maquet/Datascope IABPs, we recognize that these systems may be the best option for circulatory support for some patients. The FDA wants to ensure you are aware of these device failures that have been observed in patients treated with Maquet/Datascope IABPs and reported to the FDA," the company stated it is letter.

 

Recommendations for Providers

The FDA recommends that healthcare providers should follow each device's operating instructions manual for recommendations on usage, charging, maintenance and storage of the system batteries, since battery run times and discharge cycles vary between IABP models. 

In addition, the FDA recommends that users and servicers of Maquet/Datascope IABP devices should:
   • Ensure the IABP system is plugged into an AC outlet whenever possible during patient use to prevent the battery from depleting.
   • Ensure the IABP system is plugged into an AC outlet when the system is not in use. The batteries should be kept at a full charge even when the IABP is not in use.

When transporting patients within or between facilities, please refer to the system's Operating Instructions Manual for recommendations for portable/battery operation. For example:
   • Prior to portable operation, the battery should be fully charged.
   • Additional charged batteries should be on hand during transport, if applicable for the system. 
   • Ensure the batteries are properly seated in the battery compartment/charger. 
   • Periodically check battery run time and replace batteries as required, as recommended in each system's Operating Instructions Manual. A reduction in run time can occur over a battery's life for reasons such as age, storage temperature and discharge depth. 

Batteries should be replaced:
   • After reaching the maximum number of charge-discharge cycles. 
   • When the battery provides less than the minimum expected run time.
   • When the labeled lifetime of the battery is reached.
   • If the battery is broken, cracked, leaking or damaged. 

The vendor encourages providers to report to the FDA events of IABP devices shutting down while running on batteries, as well as any other battery issues that occur. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

When possible, return devices associated with, or suspected to be associated with, any adverse events or device malfunction to the manufacturer for evaluation to help them and the FDA better understand the issue.

The FDA is working with the device manufacturer to better understand these device shutdown events while running on battery for Maquet/Datascope IABPs, and any contributing factors. The FDA will keep the public informed if significant new information becomes available.

Links to Related Maquet IABP FDA Recalls:

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump

Maquet Datascope Corp./Getinge Group Recalls the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) Due to Possible Malfunction and Failure at High AltitudesGetinge Issues Worldwide Voluntary

Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters (September 20, 2018)

Related Content

An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

News | Cath Lab | July 22, 2021
July 22, 2021 — Medis Medical Imaging is partnering with CORRIB Core Lab and Sinomed in randomized clinical trial of
ast End Medical announced it received U.S. Food and Drug Administration (FDA) clearance for the company's SafeCross Transseptal Radiofrequency (RF) Puncture and Steerable Balloon Introducer System. The 3-in-1 system, which includes a steerable introducer sheath with an ultra-visible positioning balloon and radiofrequency (RF) puncture dilator, aims to provide a predictable and safe solution for electrophysiology (EP) and structural heart interventions requiring left atrial access.
News | Cath Lab | July 14, 2021
July 13, 2021 — East End Medical announced it received U.S.
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone. #SCAI21 #SCAI2021 Creating a card0-renal program.

There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone.

Feature | Cath Lab | May 14, 2021 | By Dave Fornell, Editor
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal fun
Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting proc

Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting procedures.

News | Cath Lab | May 12, 2021
May 12, 2021 — Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has
SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI heart attack. #SCAI21 #SCAI2021

SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI.

Feature | Cath Lab | May 06, 2021 | By Dave Fornell, Editor
April 29, 2021 — Here is the list of late-breaking study presentations and links to articles about each of them from
Most Stable Ischemic Heart Disease Patients Did Not Meet ISCHEMIA Trial Enrollment Criteria, raising questions about its application in real-world practice. #SCAI2021 Getty Images

Getty Images

News | Cath Lab | May 03, 2021
May 3, 2021 – Results from a new study find a broad range of patients who typically undergo revascularization for sta
New study demonstrates depression, HIV, mental health, obesity, alcohol and drug abuse are risk factors on most common type of heart disease in young black patients. Photo by Dave Fornell
News | Cath Lab | April 29, 2021
April 29, 2021 – A retrospective analysis of risk factors for coronary artery disease (CAD) in young African American
There are far fewer patients coming to hospitals with heart attacks during the COVID-19 pandemic as compared to averages prior to the pandemic. This has raised concerns that delayed treatment will cause an uptick in cardiac deaths and heart failure. Photo from Getty Images 

There are far fewer patients coming to hospitals with heart attacks during the COVID-19 pandemic as compared to averages prior to the pandemic. This has raised concerns that delayed treatment will cause an uptick in cardiac deaths and heart failure. Photo from Getty Images 

News | Cath Lab | April 28, 2021
April 28, 2021 – Results from a retrospective observational study, presented today at...
A cardiac cath lab at Henry Ford Hospital in Detroit. Photo by Dave Fornell

A cardiac cath lab complex PCI case at Henry Ford Hospital in Detroit. Photo by Dave Fornell

News | Cath Lab | April 28, 2021