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

Catalog Number IAP-0400

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported while on patient the intra-aortic balloon pump (iabp) alarmed for a system error 3.The iabp stopped and the staff was unable to restart.As a result, the iabp was replaced to continue treatment.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#: (b)(4).The reported complaint of "system error 3 alarm" is confirmed.The pump alarmed system error 3 (1) immediately upon power up.The root cause of this 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 while on patient the intra-aortic balloon pump (iabp) alarmed for a system error 3.The iabp stopped and the staff was unable to restart.As a result, the iabp was replaced to continue treatment.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: 11368357
• MDR Text Key: 234413047
• Report Number: 3010532612-2021-00046
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902051721
• UDI-Public: 00801902051721
• 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: 02/05/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1