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

Model Number IPN917285

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2023

Event Type  malfunction  

Event Description

It was reported that "no ecg or ap signals.Replaced fe board.Biomed states that the pump was switched out quickly with no patient complications." patient status is reported as "unchanged".

Manufacturer Narrative

Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

(b)(4).Returned for investigation was an ac3 front end board (feb) (p/n: 33-1020-003, s/n: (b)(6)).The sample was returned in the feb board shipping box without an electrostatic protective bag.Visual inspection of the front end board was performed and no abnormality was noted.The front-end board was installed into a known good ac3 for functional testing.The pump was powered on with no abnormalities.A patient simulator was connected to the pump and pumping was initiated in autopilot.Performed ecg, ap signal and trigger checklist and failed.The front end board did not recognize the ecg skin leads or the ap transducer signal.The pump properly alarmed in operator mode when there was no signal in the selected trigger mode.The pump was left to run in autopilot with the monitor signals for over 30 minutes without any further alarms or errors.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 'no ecg or ap signals" is confirmed.During the complaint investigation, the returned front end board did not detect ecg skin leads or ap transducer signals.Based on a review of the device history record (dhr), the product met specification upon release; however, the received product did not meet specifications during the complaint investigation due to the missing ecg and ap signals.The root cause of this complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

Event Description

It was reported that "no ecg or ap signals.Replaced fe board.Biomed states that the pump was switched out quickly with no patient complications." patient status is reported as "unchanged".

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16466944
• MDR Text Key: 310514307
• Report Number: 3010532612-2023-00111
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN917285
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1