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

Model Number	IPN917285
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The report states, "pump had purge failure alarm and powered down twice while on patient".At the time of this report, the customer has not returned our multiple requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).Returned for investigation were the martek power supply (p/n: 33-0063-001, s/n: (b)(6) and the battery (p/n: 4000-9022-001, l/n: 18c21c0245).The samples were returned in a brown cardboard shipping box with protective packaging.Visual inspection of the power supply and battery was performed and no abnormality was noted.The power supply and battery were installed into a known good ac3 for functional testing.The system powered-up successfully.The power supply voltage check was performed per ac3 series service manual and all output voltages were within specifications.The battery load test was performed.The iabp was run on battery until the iabp shut down.The battery was then left to charge in the iabp for over 9 hours.The full charge of the battery was 13.3 volts.The iabp gave a proper alarm when disconnected from the ac power.Pumping was initiated.The unit ran for over 90 minutes along with the proper alarms "less than 20, 10, and 5 minutes remaining".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 "powered down twice" is not confirmed.The returned power supply and battery 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
The report states, "pump had purge failure alarm and powered down twice while on patient".At the time of this report, the customer has not returned our multiple requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: AC3 OPTIMUS IABP NA/EME
• 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: 17309186
• Report Number: 3010532612-2023-00381
• Device Sequence Number: 15243312
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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 Model Number: IPN917285
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/15/2023
• 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