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

Model Number IPN001112

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the field service engineer (fse) that an error 3 pump controller occurred during use on a patient.The user switched for a functional pump, and patient is still under therapy.Capacitor from the cpm found detached and laying on the chassis bottom.There was no report of patient injury or consequence.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of the system error 3 alarm cannot be confirmed.The reported alarm could not be replicated during the complaint investigation; however, the capacitor c153 is confirmed to be detached from the circuit board.The root cause of how the capacitor detached from the circuit board is undetermined.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 by the field service engineer (fse) that an error 3 pump controller occurred during use on a patient.The user switched for a functional pump, and patient is still under therapy.Capacitor from the cpm found detached and laying on the chassis bottom.There was no report of patient injury or consequence.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; chelmsford MA
• MDR Report Key: 9552914
• MDR Text Key: 183917630
• Report Number: 3010532612-2019-00480
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• 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: 01/15/2020
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1