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

Catalog Number	IAP-0700
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "while in or, once surgeons started to use bovi, lots of arterial pressure intereference despite being in ap trigger on the iabp." additional information reports "had perfusion use another iabp, it worked better, but perfusion noted similar response during use of bovi whenin ap trigger.Tagged other pump, perfusion has it in their pump room." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was an ac3 front end board.Visual inspection of the front end board was performed and no abnormality was noted.The customer also provided videos for review.The videos show interference on the on the arterial pressure waveforms, which is consistent with the reported complaint.The front-end board was installed into a known good ac3 for functional testing.The pump was powered on with no abnormalities.A patient simulator was connected to the pump and pumping was initiated in autopilot.The front end board passed voltage check, bp transducer, and static ram memory.Performed ecg, ap signal and trigger checklist and passed.The pump was left to run for over 45 minutes without any alarms or errors.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 for "lots of arterial pressure interference despite being in ap trigger on the iabp" is confirmed based on the submitted videos; however, the returned front end board passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "while in operating room, once surgeons started to use bovi, lots of arterial pressure interference despite being in ap trigger on the iabp." additional information reports "had perfusion use another iabp, it worked better, but perfusion noted similar response during use of bovi when in ap trigger.Tagged other pump, perfusion has it in their pump room." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW AC3 OPTIMUS IABP NA/EMEA
• 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: 19226117
• Report Number: 3010532612-2024-00297
• Device Sequence Number: 8320806
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown