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 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that system error 3 alarm occurred while on patient.As a result, the intra-aortic balloon pump (iabp) was swapped out.There was no report of patient complications, serious injury or death.Biomed also stated constant tone alarm and iabp shutting off occurred while testing in biomed.Fsa found system error 3/high baseline alarm after pumping for 2 minutes.Replacing the pump assembly fixed the high baseline alarm.Fsa could not replicate constant tone alarm and pump shutting off.Performed functional checklist, iabp performed to spec.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "high baseline alarm" is confirmed.The pump alarmed a high baseline during the complaint investigation.An excessive noise was noted from the pump assembly consistent with a motor/lead screw malfunction.The root cause of this complaint is undetermined.No further action required at this time.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.

Event Description

It was reported that system error 3 alarm occurred while on patient.As a result, the intra-aortic balloon pump (iabp) was swapped out.There was no report of patient complications, serious injury or death.Biomed also stated constant tone alarm and iabp shutting off occurred while testing in biomed.Fsa found system error 3/high baseline alarm after pumping for 2 minutes.Replacing the pump assembly fixed the high baseline alarm.Fsa could not replicate constant tone alarm and pump shutting off.Performed functional checklist, iabp performed to spec.

• 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: 12312924
• MDR Text Key: 266205021
• Report Number: 3010532612-2021-00218
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1