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

Catalog Number IAP-0500

Device Problem Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the intra-aortic balloon pump (iabp) alarmed and pumping appropriately, but all led lights were blinking, and no buttons were working.As a result, the pump was swapped out.There was no report of patient complications serious injury or death.

Manufacturer Narrative

Qn#(b)(4).No iabp part or recorder strip was returned for investigation.The reported complaint of led lights blinking and not responding to press is not able to be confirmed.No part or recorder strip was returned to teleflex chelmsford for investigation.After the pump was removed, the nurse powered the pump back on and could not duplicate the reported problems.The root cause of the complaint is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

Event Description

It was reported the intra-aortic balloon pump (iabp) alarmed and pumping appropriately, but all led lights were blinking, and no buttons were working.As a result, the pump was swapped out.There was no report of patient complications serious injury or death.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9425652
• MDR Text Key: 183762449
• Report Number: 3010532612-2019-00434
• 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: 11/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1