MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 IABP NA/AJLA; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAP-0601
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during incoming inspection "there was a suspicious helium leak 2, and upon returning to the intensive care unit, the alarm occurred frequently.No creases were observed on the catheter during external observation, and the catheter was adjusted in position inside the body.The electrode position and helium capacity have also been adjusted, but the alarm still appears".As a result the pump was exchanged for another pump.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during incoming inspection "there was a suspicious helium leak 2, and upon returning to the intensive care unit, the alarm occurred frequently.No creases were observed on the catheter during external observation, and the catheter was adjusted in position inside the body.The electrode position and helium capacity have also been adjusted, but the alarm still appears".As a result the pump was exchanged for another pump.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "helium leak 2" alarm was not able to be confirmed as the product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: AC3 IABP NA/AJLA
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18507513
• Report Number: 3010532612-2024-00050
• Device Sequence Number: 7875671
• Product Code: DSP
• UDI-Device Identifier: 10801902172096
• UDI-Public: 10801902172096
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: IAP-0601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown