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

Model Number IPN000320

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the staff got a purge failure alarm.The staff had exchanged the helium tank and driveline tubing prior to calling.As a result, the pump was swapped out.There was no report of patient complication, serious injury, or death.

Event Description

It was reported that the staff got a purge failure alarm.The staff had exchanged the helium tank and driveline tubing prior to calling.As a result, the pump was swapped out.There was no report of patient complication, 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 purge failure alarm is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers of ac2's at this account with no relevant findings.All devices 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.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 12923402
• MDR Text Key: 281670086
• Report Number: 3010532612-2021-00387
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1