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

Model Number IPN000320

Device Problem Mechanical Problem (1384)

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

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

There was no patient involvement.It was reported that during a hands-on training session, the pump immediately gave a purge failure alarm and would not pump.There was an ecg and arterial pressure waveform on the pump for the trigger.There was helium in the helium tank, and the helium tank was on.The balloon catheter helium tubing was connected to the pump, and the screen showed that it was a 40 cc iab.When the on key was pressed, the pump tried to do the home-set but would not complete that and start pumping.The clinical support specialist (css) tried powering the pump down a couple of times, and this continued to happen.As a result, the pump will be taken out of service and sent to biomed to be checked.

Manufacturer Narrative

(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of persistent purge failure 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 revised risk.This will be monitored for any developing trends.

Event Description

There was no patient involvement.It was reported that during a hands-on training session, the pump immediately gave a purge failure alarm and would not pump.There was an ecg and arterial pressure waveform on the pump for the trigger.There was helium in the helium tank, and the helium tank was on.The balloon catheter helium tubing was connected to the pump, and the screen showed that it was a 40 cc iab.When the on key was pressed, the pump tried to do the home-set but would not complete that and start pumping.The clinical support specialist (css) tried powering the pump down a couple of times, and this continued to happen.As a result, the pump will be taken out of service and sent to biomed to be checked.

• 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: 13259810
• MDR Text Key: 283957496
• Report Number: 3010532612-2021-00419
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• 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