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

Model Number	IPN917285
Medical Device Problem Codes	Failure to Run on Battery (1466); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while on battery power during use on a patient transporting from the ccu to ct and back to the ccu, the battery failed and the pump suffered a complete loss of power.As a result, the pump was exchanged for another pump.No patient harm or injury.The initial pump had been plugged into ac power, per ifu.When unplugged, the pump immediately and inaccurately displayed "battery life less than " 20 min, 10 min, and 5 min in a row within seconds.The pump did not last on battery power per the indicated time left.The patient status was reported as "critical" prior to the pump battery failure.Patient condition unchanged by event.
Additional Manufacturer Narrative
(b)(4).No iabp part was returned to teleflex chelmsford for investigation.According to the field service report, a field service engineer confirmed the reported issue.As a result, the battery was replaced.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 "battery failure" was confirmed by the field service engineer.No part was returned to teleflex chelmsford for investigation.The battery was replaced by the field service engineer.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 battery failure.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.
Event or Problem Description
It was reported that while on battery power during use on a patient transporting from the ccu to ct and back to the ccu, the battery failed and the pump suffered a complete loss of power.As a result, the pump was exchanged for another pump.No patient harm or injury.The initial pump had been plugged into ac power, per ifu.When unplugged, the pump immediately and inaccurately displayed "battery life less than " 20 min, 10 min, and 5 min in a row within seconds.The pump did not last on battery power per the indicated time left.The patient status was reported as "critical" prior to the pump battery failure.Patient condition unchanged by event.

• 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: 17097300
• Report Number: 3010532612-2023-00311
• Device Sequence Number: 1932025
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/18/2023

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 07/10/2023
• 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
• Patient Sex: Male