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

Model Number IPN000302

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the intra-aortic balloon pump (iabp) was in use, the clinical found that the pressure signal and blood pressure value was not displaying.After the operation, the pressure sensor was tested and worked.The pump was tested and found a problem with the pressure signal output of the front signal processing board.As a result, the front signal processing board was replaced with a new one, and the signal displayed normally.There was no report of patient complications, serious injury or death.

Event Description

It was reported that when the intra-aortic balloon pump (iabp) was in use, the clinical found that the pressure signal and blood pressure value was not displaying.After the operation, the pressure sensor was tested and worked.The pump was tested and found a problem with the pressure signal output of the front signal processing board.As a result, the front signal processing board was replaced with a new one, and the signal displayed normally.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of iabp not displaying ap values is not able to be confirmed.Additional information indicates a service agent replaced a "front signal processing board" the issue was resolved.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: 9498175
• MDR Text Key: 183914825
• Report Number: 3010532612-2019-00449
• 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: 11/25/2019

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 Model Number: IPN000302
• Device Catalogue Number: IAP-0400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1