MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC 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 05/08/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.

Event Description

It was reported by the clinical support specialist (css) that the pump alarmed system error 3.As a result, the staff restarted the pump, and the patient was supported without issue.The reported pump will be sent to biomed.There was no report of patient complication, serious injury, or death.

Event Description

It was reported by the clinical support specialist (css) that the pump alarmed system error 3.As a result, the staff restarted the pump, and the patient was supported without issue.The reported pump will be sent to biomed.There was no report of patient complication, serious injury, or death.Additional information received stated that the alleged issue was found during preventative maintenance.The moisture bottle next to air tank was emptied, the unit was tested and the error cleared.

Manufacturer Narrative

(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The three pictures were reviewed and show a system error 3 alarm strip.The reported complaint of system error 3 alarm is confirmed based on the pictures provided.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; however, the specifications were not met during the complaint investigation due to the alarm.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
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, MA 27560
• MDR Report Key: 14601750
• MDR Text Key: 293355325
• Report Number: 3010532612-2022-00204
• 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: 05/08/2022

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 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
• Initial Date Manufacturer Received: 05/08/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 06/28/2022
• 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
• Patient Sex: Male