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

Catalog Number	IAP-0700
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " pump shut off during use 3 times.User had a toggle power switch to restart.Also observed triggering issues.Pump was swapped and no harm to patient.".
Additional Manufacturer Narrative
Qn#(b)(4).Returned for investigation was a martek power supply.Visual inspection of the power supply was performed and no abnormality was noted.The power supply was installed into a known good ac3 for functional testing.The iabp powered up successfully with no alarm.The power supply voltage check was performed per the ac3 service manual and all output voltages were present and within specification.The battery load test was performed.The iabp was run on battery until the iabp shut down.The batteries were then left to charge in the iabp for over 9 hours.The full charge of batteries was 13.0 volts.Pumping was initiated.The iabp gave a proper alarm when disconnected from the ac power.The iabp alarmed properly with "less than 20 minutes remaining", "less than 10 minutes remaining", and "less than 5 minutes remaining" alarms.The total battery runtime was over 90 minutes.The pump passed the battery load test.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of "shut off during use" is not confirmed.The returned power supply 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.
Event or Problem Description
It was reported " pump shut off during use 3 times.User had a toggle power switch to restart.Also observed triggering issues.Pump was swapped and no harm to patient.".

• 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: 19372373
• Report Number: 3010532612-2024-00375
• Device Sequence Number: 7703796
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 05/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 05/30/2024
• 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