MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC 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 01/03/2023

Event Type  malfunction  

Event Description

It was reported that the pump displayed a "purge failure" alarm when initiating therapy on a patient.The pump was swapped out for another pump and therapy was continued with no issues.No reported patient harm or injury.The psc was replaced and the pump was placed back in service.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Returned for investigation was an autocat2 pcs assembly (p/n: 96-3006-001, s/n: (b)(6)).Visual inspection of the pcs assembly was per formed and no abnormality was noted.The returned pcs assembly was installed into a known good autocat2w for functional testing.The system was powered up successfully.The pump alarmed for purge failure (5) when pumping was initiated.The pcs assembly was then re moved from the pump.All valves were individually tested by powering them on and off using an external power supply, and the vent valve v1 did not respond when the power 12 vdc was applied.Visual inspection of the pcs assembly internal hardware was performed.The release spring in the vent valve was stuck.No other abnormality was noted.A device history record (dhr) review was conducted for the serial number/lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The risk is acceptable.This will be monitored for any developing trends.The reported complaint of "purge failure alarm" is confirmed.The release spring inside the vent valve was found stuck which can cause the alarm.Based on a review of the device history record (dhr), the product met specification upon release; however, the received product did not meet specifications during the complaint investigation due to the release spring being stuck inside the vent valve.The root cause of how to release spring became stuck is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a, corrected data: n/a.

Event Description

It was reported that the pump displayed a "purge failure" alarm when initiating therapy on a patient.The pump was swapped out for another pump and therapy was continued with no issues.No reported patient harm or injury.The psc was replaced and the pump was placed back in service.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16108250
• MDR Text Key: 308011448
• Report Number: 3010532612-2023-00012
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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