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

Model Number	IPN917285
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient, "erratic triggering with good signals, occurring on both ecg and ap- pump exchanged".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of erratic triggering was confirmed based on the customer supplied photos.The product was not returned for i nvestigation.The attached photo shows erratic triggering despite good ecg and ap waveforms.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 triggering issue.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that while in use on a patient, "erratic triggering with good signals, occurring on both ecg and ap- pump exchanged".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17343638
• Report Number: 3010532612-2023-00393
• Device Sequence Number: 6524510
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: IPN917285
• Device Catalogue Number: IAP-0700
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/18/2023
• 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 Sex: Male