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

Model Number	IPN917285
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that during morning quality check, the pump was unplugged to assess battery performance.When the pump was unplugged, it shut off.The user denies any battery alarms and states that the pumps are plugged in continuously.No patient involvement.As a result, "replaced power supply, they had display issues.Replaced cpm.Found umbilical cable heath had pulled away from connection, replaced cable".
Event or Problem Description
It was reported that during morning quality check, the pump was unplugged to assess battery performance.When the pump was unplugged, it shut off.The user denies any battery alarms and states that the pumps are plugged in continuously.No patient involvement.As a result, "replaced power supply, they had display issues.Replaced cpm.Found umbilical cable heath had pulled away from connection, replaced cable".
Additional Manufacturer Narrative
(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 system powered-up successfully.The power supply voltage check was performed per the 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 battery was 13.0 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 "shuts off when unplugged" 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.

• 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: 17049720
• Report Number: 3010532612-2023-00303
• Device Sequence Number: 12510985
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/15/2023

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
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 11/29/2023
• 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