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

Model Number IPN000302

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

There was no patient involvement.The issue was encountered prior to use on the patient during inspection/functional testing.It was reported that the nurses in the intervention room conducted daily start up test on the intra-aortic balloon pump (iabp) and found the iabp could not be turned on normally to the operation interface, and alarmed.

Event Description

There was no patient involvement.The issue was encountered prior to use on the patient during inspection/functional testing.It was reported that the nurses in the intervention room conducted daily start up test on the intra-aortic balloon pump (iabp) and found the iabp could not be turned on normally to the operation interface, and alarmed.

Manufacturer Narrative

Qn#(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of iabp: power supply not functioning is not able to be confirmed.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: AUTOCAT 2
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11065413
• MDR Text Key: 223453328
• Report Number: 3010532612-2020-00390
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1