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

Catalog Number IAP-0700

Device Problems Erratic or Intermittent Display (1182); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the field engineer that on the intra-aortic balloon pump (iabp) a weird display screen appears.The electrocardiogram (ecg) and pressure freezes, and gas icon and battery icon go to red x.As a result, the cpm board was replaced.There was no reported patient injury or consequence.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of waveforms frozen with red x on helium and battery icon was confirmed by the field service technician.As a result, the field service replaced the cpm board.The root cause of the complaint is undetermined.If the part is received at a later date, the notification will be reopened, and a full investigation will be completed.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.Other remarks: this complaint was reopened to investigate the device that was returned to teleflex for investigation.The reported complaint of waveforms frozen with red x's on the helium and battery icon was confirmed by the field service technician.However, the symptoms could not be duplicated during the complaint investigation of the returned cpm board.The root cause of the 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 revised risks.This will be monitored for any developing trends.A corrective and preventive action request has been initiated for the issue.

Event Description

It was reported by the field engineer that on the intra-aortic balloon pump (iabp) a weird display screen appears.The electrocardiogram (ecg) and pressure freezes, and gas icon and battery icon go to red x.As a result, the cpm board was replaced.There was no reported patient injury or consequence.

Event Description

It was reported by the field engineer that on the intra-aortic balloon pump (iabp) a weird display screen appears.The electrocardiogram (ecg) and pressure freezes, and gas icon and battery icon go to red x.As a result, the cpm board was replaced.There was no reported patient injury or consequence.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of waveforms frozen with red x on helium and battery icon was confirmed by the field service technician.As a result, the field service replaced the cpm board.The root cause of the complaint is undetermined.If the part is received at a later date, the notification will be reopened, and a full investigation will be completed.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

• 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: 9087964
• MDR Text Key: 159317052
• Report Number: 3010532612-2019-00360
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2019

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 Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 10/14/2019; 01/29/2020
• Supplement Dates FDA Received: 10/17/2019; 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1