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	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, "during the unpacking inspection and simulation test run, when using the simulator or built-in mode, it was found that the platform period of the counterpulsation remained high at about 185, while under the same conditions, the platform period was about 125 when other machines were running.When using a sample balloon for counterpulsation, the machine will alarm for high pressure, helium leakage, etc., and stop the counterpulsation.It is preliminarily determined that this machine has a malfunction".No patient involvement.
Event or Problem Description
It was reported that, "during the unpacking inspection and simulation test run, when using the simulator or built-in mode, it was found that the platform period of the counterpulsation remained high at about 185, while under the same conditions, the platform period was about 125 when other machines were running.When using a sample balloon for counterpulsation, the machine will alarm for high pressure, helium leakage, etc., and stop the counterpulsation.It is preliminarily determined that this machine has a malfunction".No patient involvement.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of high bpw was confirmed based on the pictures provided in the complaint.No iabp part strip was returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to high balloon pressure.The root cause of the complaint was undetermined.No further action was required at this time.Teleflex will continue to monitor and trend for reports 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: 17388929
• Report Number: 3010532612-2023-00412
• Device Sequence Number: 20351873
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/28/2023
• 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