Cause of Device-Related Incident
Device factors; User errors

Clinical Specialty or Hospital Department
Cardiology / Cardiac Catheterization; Cardiopulmonary Perfusion; Cardiothoracic Surgery; Clinical/Biomedical Engineering

Device Factors
Improper maintenance, testing, repair, or lack or failure of incoming inspection

Document Type
User Experience Network (UEN) reports

External Factors
*Not stated

Mechanism of Injury or Death
Failure to deliver therapy

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
Incorrect control settings

UMDNS
Circulatory Assist Units, Intra-Aortic Balloon [10-846]

Intra-Aortic Balloon Pumps: Inspection and Infrequent Use



User Experience Network™ [Health Devices Feb 1993;22(2):96]

Hospital

We use the intra-aortic balloon pump (IABP) in our cardiac catheterization laboratory (cath lab) very infrequently and are wondering whether we should reduce our current biannual inspection and preventive maintenance (IPM) interval to one time per year.

ECRI

Because the IABP is a critical life-support device with components such as rechargeable batteries and compressors that need to be checked and operated periodically, we recommend that you continue biannual inspections.

Of equal concern, however, is that clinicians in your hospital may be using the pump only one or two times per year. Intra-aortic balloon pumping is a support modality that should be provided by experienced clinicians who work with the machines regularly. While modern pumps are easy to set up, the circumstances in which they are used are complex, considering that patients may have a wide range of cardiac-related conditions. Used improperly, the pump can actually do more harm than good.

If your hospital intends to keep the IABP in the cath lab, we recommend that you locate a perfusion service that can provide you with current balloon pumping expertise, when needed. Relying on hospital clinicians who rarely use the pump to operate it during emergencies may expose your patients to unnecessary risks.

UMDNS Term

Circulatory Assist Units, Intra-Aortic Balloon [10-846]

Cause of Device-Related Incident

Device factor: Improper maintenance, testing, repair, or lack or failure of incoming inspection

User error: Incorrect control settings

Mechanism of Injury or Death

Failure to deliver therapy 

 


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