MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. 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 06/06/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the staff called for help with persistent helium loss and purge failure alarms.The intra-aortic balloon pump (iabp) will only run for about 1-2 minutes between alarms.There does not appear to be any blood in the gas tubing.The patient was transferred to them from another hospital with a maquet 34cc intra-aortic balloon (iab) in place.The staff had already changed the adaptor out with no change to the alarms.All connections were checked to make sure that all are secure.Still the alarms persisted.The clinical support specialist (css) advised the staff to try one more adaptor, but the alarms persisted.As a result, the iabp was switch out for another.This solved the problem.The problem pump will be sent to biomed to be checked.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the staff called for help with persistent helium loss and purge failure alarms.The intra-aortic balloon pump (iabp) will only run for about 1-2 minutes between alarms.There does not appear to be any blood in the gas tubing.The patient was transferred to them from another hospital with a maquet 34cc intra-aortic balloon (iab) in place.The staff had already changed the adaptor out with no change to the alarms.All connections were checked to make sure that all are secure.Still the alarms persisted.The clinical support specialist (css) advised the staff to try one more adaptor, but the alarms persisted.As a result, the iabp was switch out for another.This solved the problem.The problem pump will be sent to biomed to be checked.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of helium loss and purge failure alarm is not able to be confirmed.If the part or additional information received at a later day, a full investigation will be completed.The root cause of the complaint is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12120568
• MDR Text Key: 260016520
• Report Number: 3010532612-2021-00173
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (y/n): N
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• 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?: Yes
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1