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	Insufficient Information (4580)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "pump is being used in operating room in ap trigger due to bovie use.Arterial pressure has artifact and is being picked up at significantly higher rate that actual heart rate and creating excessive triggering.Video of issue was sent to my cell phone." the pump was not replaced.No patient harm or injury.No medical intervention required.The patient's current condition is "unknown" at this time.
Event or Problem Description
It was reported "pump is being used in operating room in ap trigger due to bovie use.Arterial pressure has artifact and is being picked up at significantly higher rate that actual heart rate and creating excessive triggering.Video of issue was sent to my cell phone." the pump was not replaced.No patient harm or injury.No medical intervention required.The patient's current condition is "unknown" at this time.
Additional Manufacturer Narrative
(b)(4) no iabp part was returned to teleflex chelmsford for investigation.The customer provided a video for evaluation.The video shows artifacting on the arterial pressure and picked up at significantly higher heart rate, which created the excessive triggering consistent with the event details.The specific serial number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.The reported complaint of "arterial pressure has artifact and is being picked up at significantly higher rate that actual heart rate and creating excessive triggering" is confirmed based on the video provided in the complaint.The video shows artifacting on the arterial pressure and picked up at significantly higher heart rate, which created the excessive triggering consistent with the event details.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 the abnormal ap trigger.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

• 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: 19216470
• Report Number: 3010532612-2024-00288
• Device Sequence Number: 6960937
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K162820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown