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

Model Number	IPN917286
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The report states that the "[arrow ac3] iabp switch itself off, while in use, approximately 30 seconds after the initial 20 minute warning.History of this pump last serviced in december 2021 and battery replaced at this time.Service now due." as a result, the pump was swapped out.There was no report of patient complications, serious injury or death.Further information states "the patient had the catheter inserted on the 28th dec as she was critically ill as she was presenting with an acute myocardial infarction.She had no adverse event because of the battery failure and has recovered from her critical condition".
Event or Problem Description
The report states that the "[arrow ac3] iabp switch itself off, while in use, approximately 30 seconds after the initial 20 minute warning.History of this pump last serviced in december 2021 and battery replaced at this time.Service now due." as a result, the pump was swapped out.There was no report of patient complications, serious injury or death.Further information states "the patient had the catheter inserted on the 28th dec as she was critically ill as she was presenting with an acute myocardial infarction.She had no adverse event because of the battery failure and has recovered from her critical condition".
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of short battery runtime is not able to be confirmed.No part was returned to teleflex chelmsford for investi gation.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.Iabp users and servicers must follow the operating instructions manual for recommendations on usage, charging, maintenance and storage of the batteries.If battery maintenance is not performed per the iabp operating instructions manual, the battery may not provide the expected minimum run time of operating power.

• Brand Name: AC3 OPTIMUS IABP NA/AJLA
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16277839
• Report Number: 3010532612-2023-00018
• Device Sequence Number: 6871180
• Product Code: DSP
• UDI-Device Identifier: 10801902172072
• UDI-Public: 10801902172072
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: IPN917286
• Device Catalogue Number: IAP-0701
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 02/24/2023
• 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: N/A.; N/A.
• Patient Sex: Unknown