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

Catalog Number	IAP-0701
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the inspection of the iabp, high baseline alarm occurred.The alarm occured again after changing the balloon simulator.The cpm board and motor driver were replaced, but the alarm was not resolved.After that, the pump assembly was replaced and the issue was resolved." no patient involvement reported.
Additional Manufacturer Narrative
(b)(4) returned for investigation was an ac3 pump assembly.Visual inspection of the pump assembly was performed and no abnormality for noted.The pump assembly was installed into a known good lab inventory ac3 for functional testing.The pump was successfully powered up.Pumping was initiated.A grinding noise was noted from the pump assembly and the pump alarmed high baseline (1) approximately 34 minutes after pumping was initiated.The top of the pump assembly's bellows box was opened, and pumping was initiated to more closely determine the grinding noise noted.It was noted the grinding sound appeared to be coming from the lead screw which drives the bellows.No closer inspection to what was causing the grinding sound could be completed.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of high baseline alarm is confirmed.The pump alarmed a high baseline (1) during the complaint investigation.A griding noise was noted from the pump assembly consistent with a motor/lead screw malfunction.Based on a review of the device history record (dhr), the product met specification upon release; however, the received product did not meet specifications during the complaint investigation due to the motor/lead screw malfunction.The root cause of this complaint is undetermined.This will be monitored for any developing trends.A non-conformance has been initiated to further investigate the issue.
Event or Problem Description
It was reported that "during the inspection of the iabp, high baseline alarm occurred.The alarm occured again after changing the balloon simulator.The cpm board and motor driver were replaced, but the alarm was not resolved.After that, the pump assembly was replaced and the issue was resolved." no patient involvement reported.

• Brand Name: AC3 OPTIMUS 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18681575
• Report Number: 3010532612-2024-00095
• Device Sequence Number: 7217437
• Product Code: DSP
• UDI-Device Identifier: 30801902091254
• UDI-Public: 30801902091254
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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
• Device Catalogue Number: IAP-0701
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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