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

Catalog Number	IAP-0700
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The medwatch report states, "patient's (intra-aortic balloon pump) began alarming for high pressure alarms (around three separate instances over the course of an hour) causing the pump to shut off and need to be manually restarted.The patient was repositioned to be as flat as possible each time and the line was inspected to ensure there was not kinking or bending present.The (intra-aortic balloon pump) console then alarmed "system error 3, pump/valve controller error" and shut off again.The line and patient were again inspected with no changes found and the pump was restarted as per the instructions on the console window.The alarm happened two more times with the pump being restarted by staff before the engineer arrived and had to switch out the console.The effected console was taken away by the (intra-aortic balloon pump) engineer." at the time of this report, the customer has not returned our requests for additional information.
Additional Manufacturer Narrative
(b)(4).Udi number unavailable as complainant did not report a lot number.The reported complaint of "system error 3 and high pressure alarms" is not able to be confirmed.No part was returned to teleflex chelmsford for investigation.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.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The medwatch report states, "patient's (intra-aortic balloon pump) began alarming for high pressure alarms (around three separate instances over the course of an hour) causing the pump to shut off and need to be manually restarted.The patient was repositioned to be as flat as possible each time and the line was inspected to ensure there was not kinking or bending present.The (intra-aortic balloon pump) console then alarmed "system error 3, pump/valve controller error" and shut off again.The line and patient were again inspected with no changes found and the pump was restarted as per the instructions on the console window.The alarm happened two more times with the pump being restarted by staff before the engineer arrived and had to switch out the console.The effected console was taken away by the (intra-aortic balloon pump) engineer." at the time of this report, the customer has not returned our requests for additional information.

• Brand Name: 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: 19374720
• Report Number: 3010532612-2024-00384
• Device Sequence Number: 12639858
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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-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: 04/25/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown