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

Catalog Number	IAP-0700
Medical Device Problem Code	Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "pump switching to ap trigger with bovi.Prior to the trigger switch, ecg and ap signal good, after trigger switch, artifact noted on ap waveform and erratic triggering.Minimal noise artifact noted when pump is in standby.Pump pumping 1:1 although 1:2 ratio selected.No other devices plugged into power outlet, no slaved signals.Patient in unit, currently working 'ok' in 1:2, less artifact than in 1:1".No patient harm on injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The product was not returned for investigation.The photos provided by the customer were reviewed and show noise on the ecg and ap waveforms.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of "arterial pressure artifact" is confirmed based on the photos received.The product was not returned for investigation.The pictures show artifacting on the 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 waveform artifacting.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 "pump switching to ap trigger with bovi.Prior to the trigger switch, ecg and ap signal good, after trigger switch, artifact noted on ap waveform and erratic triggering.Minimal noise artifact noted when pump is in standby.Pump pumping 1:1 although 1:2 ratio selected.No other devices plugged into power outlet, no slaved signals.Patient in unit, currently working 'ok' in 1:2, less artifact than in 1:1".No patient harm on 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19461707
• Report Number: 3010532612-2024-00406
• Device Sequence Number: 6661990
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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-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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/27/2024
• 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: Unknown