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

Model Number	IPN917287
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "we had an incident with one of the balloon pumps today during a primary and resulted with us having to transfer balloon pumps.The pump has been left on charge but does not seem to hold any charge when disconnected from the mains and then the screen and pump cut out without alarming." no report of patient harm or injury.The patient status before and after the event is reported as "critical".
Event or Problem Description
It was reported that "we had an incident with one of the balloon pumps today during a primary and resulted with us having to transfer balloon pumps.The pump has been left on charge but does not seem to hold any charge when disconnected from the mains and then the screen and pump cut out without alarming." no report of patient harm or injury.The patient status before and after the event is reported as "critical".
Additional Manufacturer Narrative
(b)(4).The reported complaint of the pump not holding a charge is not able to be confirmed.The product was not returned 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.Other remarks: n/a.Corrected data: n/a.

• Brand Name: AC3 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: 17543981
• Report Number: 3010532612-2023-00448
• Device Sequence Number: 15304312
• Product Code: DSP
• UDI-Device Identifier: 10801902172089
• UDI-Public: 10801902172089
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/28/2023

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: IPN917287
• Device Catalogue Number: IAP-0600
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/19/2023
• 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: Unknown