MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT 2; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAP-0400
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor on duty noticed that the equipment displayed an alarm of 'helium leakage (4)' and a crash occurred (the screen showed, but the buttons could not perform the operation function, and the equipment could not be used normally).The doctor immediately removed the equipment and catheter.This malfunction occurred during the patient's treatment process".Additional information states that there was no visible defect to the catheter.A new pump and catheter were not inserted as "the doctor used other treatment after removal of the equipment and catheter".No medical intervention required.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor on duty noticed that the equipment displayed an alarm of 'helium leakage (4)' and a crash occurred (the screen showed, but the buttons could not perform the operation function, and the equipment could not be used normally).The doctor immediately removed the equipment and catheter.This malfunction occurred during the patient's treatment process".Additional information states that there was no visible defect to the catheter.A new pump and catheter were not inserted as "the doctor used other treatment after removal of the equipment and catheter".No medical intervention required.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of "helium leakage (4)" 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: AUTOCAT 2
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17690538
• Report Number: 3010532612-2023-00491
• Device Sequence Number: 6032927
• Product Code: DSP
• UDI-Device Identifier: 30801902051722
• UDI-Public: 30801902051722
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: IAP-0400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/10/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Female