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 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

During preventative maintenance for the battery, the pump encountered a purge failure alarm.As a result, the battery and pcs assy were replaced.No patient involvement.

Manufacturer Narrative

Qn#(b)(4).Returned for investigation was an autocat2 pcs assembly.Visual inspection of the pcs assembly was performed.A dried white substance was noted on the posterior side of the pcb.No other abnormalities were noted.The pcs assembly was installed into a known good lab inventory ac2 for functional testing.The pump started up successfully.Pumping was initiated.During purge cycle, the pump alarmed purge failure.Pumping was reinitiated, with the same result.The pcs assembly was removed from the pump.Each valve was connected to a 12v dc power supply to check proper function.V2, v3, and v4 responded properly to the 12v supplied with an audible click, indicating proper valve function.V1 did not respond properly.Visual inspection of the pcs assembly internal hardware was performed.Blood was noted inside valves v1 and v4.V4 had the most significant buildup of dried blood.V1 had a small amount of dried blood in the valve which caused it to stick.Upon disassembling and reassembling v1, the valve responded properly to the 12v supplied voltage, indicating the blood contamination in the valve caused the valve to not be able to open/close properly.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.The reported complaint of purge failure alarms is confirmed.Dried blood was noted in several internal components and caused the v1 valve to not respond properly to the applied voltage.During the complaint investigation, the iabp alarmed purge failure.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 dried blood buildup inside the pcs assembly.The root cause of how the blood entered the pcs assembly 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

During preventative maintenance for the battery, the pump encountered a purge failure alarm.As a result, the battery and pcs assy were replaced.No patient involvement.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16832068
• MDR Text Key: 314178058
• Report Number: 3010532612-2023-00230
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• 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
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: No
• 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