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

Model Number IPN001112

Device Problem Mechanical Problem (1384)

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

Event Date 04/03/2023

Event Type  malfunction  

Event Description

It was reported that "error detected during preventative maintenance; the pump displayed system error 3 (pump controller cpu failure) during testing".No patient involvement.

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

(b)(4).Returned for investigation was an ac3 pump assembly without the pcs assembly.Visual inspection of the pump assembly was performed and no abnormality was noted.A known good lab inventory pcs assembly was installed onto the pump assembly.The pump assembly was then installed into a known good lab inventory ac3 for functional testing.The pump was successfully powered up.Pumping was initiated.A grinding noise was noted from the pump assembly and the pump alarmed high baseline (1) approximately 1 minute after pumping was initiated.The top of the pump assembly's bellows box was opened, and pumping was initiated to more closely determine the grinding noise noted.It was noted the grinding sound appeared to be coming from the lead screw which drives the bellows.No closer inspection to what was causing the grinding sound could be completed.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of system error 3 alarm is confirmed.The pump alarmed a high baseline (1) during the complaint investigation.A griding noise was noted from the pump assembly consistent with a motor/lead screw malfunction.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 motor/lead screw malfunction.The root cause of this complaint is undetermined.This will be monitored for any developing trends.A non-conformance has been initiated to further investigate the issue.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "error detected during preventative maintenance; the pump displayed system error 3 (pump controller cpu failure) during testing".No patient involvement.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16735338
• MDR Text Key: 313246032
• Report Number: 3010532612-2023-00215
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902172065
• UDI-Public: 10801902172065
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN001112
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2023
• 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