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

Model Number	IPN001113
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4) n/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that, "during use, the machine alarm suddenly indicated that 'the pump stopped for more than three minutes', and after three minutes the machine started to automatically reboot.Immediately stop using and contact the engineer." no patient harm or injury.Additional information received states "the patient condition is fine.Our engineer go to hospital, and do the test, no repeat failure occurred".It is unclear from the customer if the pump was swapped out for another.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "the pump stopped" and "the machine started to automatically reboot" is not able to be confirmed.The product was not returned for investigation.A field service engineer checked the pump and was unable to replicate the issue.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 or Problem Description
It was reported that, "during use, the machine alarm suddenly indicated that 'the pump stopped for more than three minutes', and after three minutes the machine started to automatically reboot.Immediately stop using and contact the engineer." no patient harm or injury.Additional information received states "the patient condition is fine.Our engineer go to hospital, and do the test, no repeat failure occurred".It is unclear from the customer if the pump was swapped out for another.If further information is received, the complaint file will be updated.

• Brand Name: AC3 OPTIMUS IABP NA/AJLA
• 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: 17019679
• Report Number: 3010532612-2023-00295
• Device Sequence Number: 6286461
• 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): 05/08/2023

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 Model Number: IPN001113
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/27/2023
• 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: 53 YR
• Patient Sex: Male