MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IPN000320

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2020

Event Type  malfunction  

Event Description

Patient was received from operating room status post a coronary artery bypass graft of 3 vessels.Patient was brought to cath lab 3 with balloon pump in place from operating room.Post percutaneous coronary intervention, while transporting patient to ctic, the balloon pump lost power repeatedly, alarming low battery despite having been plugged in for hours.Staff, including rt, anesthesia, 2 cath lab nurses and the operating room pa-c had to stop every 20-30 feet at power outlets to plug in the balloon pump to keep it functioning.Patient was brought to room on ctic, where the pump was plugged in.

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10390184
• MDR Text Key: 202365417
• Report Number: 10390184
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000320
• Device Catalogue Number: IAP-0500
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA