MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT 2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN000329
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported that intra-aortic balloon pump (iabp) had a precipitous drop in battery power while on patient when exiting the helicopter and the staff quickly plugged the iabp to an outlet.As a result, the iabp was swapped out with the hospital's iabp.The patient had no adverse outcome.
Event or Problem Description
It was reported that intra-aortic balloon pump (iabp) had a precipitous drop in battery power while on patient when exiting the helicopter and the staff quickly plugged the iabp to an outlet.As a result, the iabp was swapped out with the hospital's iabp.The patient had no adverse outcome.
Additional Manufacturer Narrative
Qn#(b)(4).No iabp part or recorder strip has been returned to teleflex chelmsford for investigation.The reported complaint of iabp drop in battery power is not able to be confirmed.The pump was serviced by a teleflex field service engineer and the reported issue could not be duplicated.It was reported by the field service engineer that the pump ran for 90 minutes before issuing an alarm to report approximately 20 minutes of battery remaining.The pump passed functional checkout.The root cause of the complaint is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

• Brand Name: AEROAUTOCAT 2 WAVE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10733985
• Report Number: 3010532612-2020-00318
• Device Sequence Number: 19274449
• Product Code: DSP
• UDI-Device Identifier: 30801902051739
• UDI-Public: 30801902051739
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: IPN000329
• Device Catalogue Number: IAP-0535
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1