MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 OPTIMUS IABP NA/AJLA; SYSTEM, BALLOON, INTRA-AORTIC AND CO

Catalog Number	IAP-0701
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the patient was admitted to icu after coronary artery bypass surgery resection of ventricular aneurysm, and iabp was used to assist circulation.On the morning of (b)(6) 2023, the iabp repeatedly reported system malfunction 3, and immediately replaced the patient with an iabp machine for treatment.No harm was caused to the patient, and the engineer was immediately contacted for maintenance and testing".No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that "the patient was admitted to icu after coronary artery bypass surgery resection of ventricular aneurysm, and iabp was used to assist circulation.On the morning of (b)(6), 2023, the iabp repeatedly reported system malfunction 3, and immediately replaced the patient with an iabp machine for treatment.No harm was caused to the patient, and the engineer was immediately contacted for maintenance and testing".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4), the reported complaint of "system error 3 alarm" is not able to be confirmed.No part or recorder strip was returned 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: AC3 OPTIMUS IABP NA/AJLA
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CO
• 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: 17585964
• Report Number: 3010532612-2023-00472
• Device Sequence Number: 4917280
• Product Code: DSP
• UDI-Device Identifier: 30801902091254
• UDI-Public: 30801902091254
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/03/2023

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-0701
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown