MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000320

Device Problems Battery Problem (2885); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) would keep switching back and forth from ac power to battery power.The power cord was checked to be secure and the iabp was plugged into multiple different outlets with no change.The patient remained supported by the iabp with no disruption.As a result, the iabp was swapped out.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the intra-aortic balloon pump (iabp) would keep switching back and forth from ac power to battery power.The power cord was checked to be secure and the iabp was plugged into multiple different outlets with no change.The patient remained supported by the iabp with no disruption.As a result, the iabp was swapped out.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).No iap part was returned to teleflex chelmsford for investigation.The reported complaint of the pump keeps switching back and forth from ac power to battery power is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the iap serial and 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: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9826035
• MDR Text Key: 183178451
• Report Number: 3010532612-2020-00061
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (y/n): N
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000320
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1