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

Model Number IPN000320

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 02/04/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported as "drain failure alarms, excessive water buildup alarm".As reported by a teleflex clinical support specialist, "[clinician] called regarding multiple drain failure alarms.She stated it was approximately every 10-20 minutes for the past "3-4 hours".No change in bpw during alarms.We verified the condensation bottle was empty and there was no condensation buildup in the driveline.I had her attempt a manual purge x3.Pump continued to alarm.I recommended she swap out the pump and send the current pump to biomed, to which she was agreeable." no patient harm or injury, patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The reported complaint of drain failure alarm was confirmed by the field service agent.As a result, the pcs assembly was replaced.No part 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.

Event Description

Reported as "drain failure alarms, excessive water buildup alarm".As reported by a teleflex clinical support specialist, "[clinician] called regarding multiple drain failure alarms.She stated it was approximately every 10-20 minutes for the past "3-4 hours".No change in bpw during alarms.We verified the condensation bottle was empty and there was no condensation buildup in the driveline.I had her attempt a manual purge x3.Pump continued to alarm.I recommended she swap out the pump and send the current pump to biomed, to which she was agreeable." no patient harm or injury, patient status is reported as "fine".

• 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: 16313539
• MDR Text Key: 309143012
• Report Number: 3010532612-2023-00089
• 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: 02/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2023
• 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