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

Model Number IPN000320

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after changing the helium tank, the pump would "not recognize the tank".It was noted that the staff tried 4 tanks.The clinical support specialist explained that the tanks may have been empty, but the staff had already sent the pump to be checked.As a result, the staff used another pump without any alarms or issues.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of "unable to recognize the helium tank" 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/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 revised risk.This will be monitored for any developing trends.

Event Description

It was reported that after changing the helium tank, the pump would "not recognize the tank".It was noted that the staff tried 4 tanks.The clinical support specialist explained that the tanks may have been empty, but the staff had already sent the pump to be checked.As a result, the staff used another pump without any alarms or issues.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: 12599085
• MDR Text Key: 275450513
• Report Number: 3010532612-2021-00330
• 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: 09/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000320
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1