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

Catalog Number IAP-0700

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) had a system error 3 alarm, 30-minutes after starting up.A power cycle was made on the iabp to resume pumping, but the iabp continued to alarm.As a result, the iabp was switched out.The iabp was sent to biomed for a functional check.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).The reported complaint of "system error 3 alarm" is confirmed based on the picture of the recorder strips provided in the complaint and the fluid on the cpm board found by the field service engineer during the service of the pump; however, no parts were returned to teleflex for investigation.The root cause of how the fluid got inside the pump is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon pump (iabp) had a system error 3 alarm, 30-minutes after starting up.A power cycle was made on the iabp to resume pumping, but the iabp continued to alarm.As a result, the iabp was switched out.The iabp was sent to biomed for a functional check.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

• 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: 8570701
• MDR Text Key: 143817318
• Report Number: 3010532612-2019-00121
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902084965
• UDI-Public: 00801902084965
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1