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

Model Number IPN000302

Device Problems Mechanical Problem (1384); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump alarmed for "system error 3, and the pneumatic system stop pumping during the procedure".As a result, staff press the start button again and pump come back to work.There was no report of delay in therapy.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No iap part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of "system error 3 alarm" is not able to be confirmed.The distributor's field service engineer serviced the pump and no problem was found with pump.The pump passed preventative maintenance (pm).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 that the intra-aortic balloon pump alarmed for "system error 3, and the pneumatic system stop pumping during the procedure".As a result, staff press the start button again and pump come back to work.There was no report of delay in therapy.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: AUTOCAT 2
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9903402
• MDR Text Key: 185961504
• Report Number: 3010532612-2020-00086
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051722
• UDI-Public: 30801902051722
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000302
• Device Catalogue Number: IAP-0400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1