MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC /TELEFLEX, INCORPORATED. ARROW 40CC IABP 8.0 FR; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number BS1063

Device Problems Device Alarm System (1012); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 09/10/2021

Event Type  malfunction  

Event Description

Patient had an iabp that was alarming during the dayshift which was resolved with the rep.The rep told the rn that if it alarmed again that it was probably and internal helium loss.The machine alarmed again, and nightshift and the staff performed trouble shooting with the rep who informed them the device needed to come out.

• Brand Name: ARROW 40CC IABP 8.0 FR
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC /TELEFLEX, INCORPORATED.; po box 12600; durham NC 27709
• MDR Report Key: 12623296
• MDR Text Key: 276157793
• Report Number: 12623296
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: BS1063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2021
• Date Report to Manufacturer: 10/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA