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

Catalog Number	IAP-0500
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "purge failure even after troubleshooting".Additionally it was reported " when the use tried to initiate support they immediately got a purge failure alarm.Ecg and arterial pressure waveform (from the fiberoptic) present.The gas tubing was connected and here was helium.The user double checked that the helium was turned on and it was.The user attempted to initiate pumping again and got a second purge failure alarm." to continue therapy the pump was switched with another autocat 2 wave.No patient injury or consequence reported.Patient's current condition reported as "fine".
Event or Problem Description
It was reported "purge failure even after troubleshooting".Additionally it was reported " when the use tried to initiate support they immediately got a purge failure alarm.Ecg and arterial pressure waveform (from the fiberoptic) present.The gas tubing was connected and here was helium.The user double checked that the helium was turned on and it was.The user attempted to initiate pumping again and got a second purge failure alarm." to continue therapy the pump was switched with another autocat 2 wave.No patient injury or consequence reported.Patient's current condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "purge failure alarms" is not able to be confirmed.No part or recorder strip was returned to teleflex chelmsford for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

• Brand Name: AUTOCAT2 WAVE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18922138
• Report Number: 3010532612-2024-00199
• Device Sequence Number: 18018818
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2024

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 Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AUTOCAT 2 WAVE; AUTOCAT 2 WAVE
• Patient Sex: Female