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 Consequences Or Impact To Patient (2199)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) had a high baseline and system error 3 alarm while on patient.As a result, the iabp was swapped out quickly without any patient issues.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4) teleflex received the device for investigation.The reported complaint of "high baseline and system error 3 alarm" is confirmed.A loose connector pin on the output cable was noted which was the result of the alarms.The root cause of this 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 revived risk.This will be monitored for any developing trends.

Event Description

It was reported that the intra-aortic balloon pump (iabp) had a high baseline and system error 3 alarm while on patient.As a result, the iabp was swapped out quickly without any patient issues.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the intra-aortic balloon pump (iabp) had a high baseline and system error 3 alarm while on patient.As a result, the iabp was swapped out quickly without any patient issues.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of "high baseline and system error 3 alarm" is confirmed.During the investigation, the returned m-force motor driver assembly was installed in a pump and alarmed for "system error 3".A loose connector pin on the output cable of the m-force was noted, and caused the alarms.A non-conformance has been initiated to further investigate the issue.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.

• 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: 11367781
• MDR Text Key: 242462397
• Report Number: 3010532612-2021-00041
• 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,Followup
• Report Date: 02/05/2021

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: IPN001112
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 03/26/2021; 05/27/2021
• Supplement Dates FDA Received: 04/01/2021; 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1