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

Catalog Number	IAP-0700
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch " within 14 minutes intraaortic balloon pump went from fully charged to 20 minutes of power remaining.Pump was plugged into helicopter.On arrival to west pad, pump stated fully charged we unloaded patient (maybe 10 minutes) iabp shut off.Pump was restarted and shut off again.Iabp was plugged into wall outlet on helipad ccu was called to advise them of this issue, they stated it is a common problem.Iabp shows 80% power, crew then gets on elevator and iabp shut off again.We made it to the room and plugged it in.Additional information states that there was no consequeneces to the patient.However, the patient's current status is unknown.
Additional Manufacturer Narrative
(b)(4).Medwatch report number : (b)(6).
Event or Problem Description
It was reported via medwatch " within 14 minutes intraaortic balloon pump went from fully charged to 20 minutes of power remaining.Pump was plugged into helicopter.On arrival to west pad, pump stated fully charged we unloaded patient (maybe 10 minutes) iabp shut off.Pump was restarted and shut off again.Iabp was plugged into wall outlet on helipad ccu was called to advise them of this issue, they stated it is a common problem.Iabp shows 80% power, crew then gets on elevator and iabp shut off again.We made it to the room and plugged it in.Additional information states that there was no consequeneces to the patient.However, the patient's current status is unknown.
Additional Manufacturer Narrative
(b)(4) the reported complaint of short battery runtime is not able to be confirmed.No part was returned to teleflex chelmsford for investigation.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 services 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/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: 19260955
• Report Number: 3010532612-2024-00341
• Device Sequence Number: 2582422
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K162820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/03/2024
• 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: Unknown