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 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Teleflex reassessed the information contained in this complaint and determined that it should have been submitted to fda as a 30-day report in accordance with 21 cfr part 803.This report is being submitted as a combined initial 30-day and follow up to include our investigation findings.Teleflex investigation findings: teleflex received the device for investigation.The reported complaint of the motor driver connector and cable connector burnt is confirmed.Upon return, discoloration consistent with burn marks was noted on the motor driver connector and on the motor driver cable.The returned devices were too damaged to analyze.A capa investigation; determined the root cause of the burnt connectors is a combination of the molex connector on the motor driver pcb and the motor driver cable.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.

Event Description

There was no patient involvement.It was reported that the nurse checked the pump for routine check, and during power-up the nurse received a system error 3 alarm.The pump was sent to be service and it was found that the connector was burned.

Manufacturer Narrative

(b)(4).Teleflex reassessed the information contained in this complaint and determined that it should have been submitted to fda as a 30-day report in accordance with 21 cfr part 803.This report is being submitted as a combined initial 30-day and follow up to include our investigation findings.Teleflex investigation findings: teleflex received the device for investigation.The reported complaint of the motor driver connector and cable connector burnt is confirmed.Upon return, discoloration consistent with burn marks was noted on the motor driver connector and on the motor driver cable.The returned devices were too damaged to analyze.A capa investigation; determined the root cause of the burnt connectors is a combination of the molex connector on the motor driver pcb and the motor driver cable.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.

Event Description

There was no patient involvement.It was reported that the nurse checked the pump for routine check, and during power-up the nurse received a system error 3 alarm.The pump was sent to be service and it was found that the connector was burned.

• 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: 11960134
• MDR Text Key: 258295727
• Report Number: 3010532612-2021-00174
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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: 03/16/2020
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1