MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/AJLA; SYSTREM INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0701

Device Problems No Device Output (1435); Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) had no arterial pressure (ap) signal after connecting the ap cable.Another cable was used to troubleshoot and the same issue occurred.As a result, the pump was exchanged for another and the signal was clear.Therapy was continued without further complications to patient and case completed successfully.There was no report of patient complications or injury.

Event Description

It was reported that the intra-aortic balloon pump (iabp) had no arterial pressure (ap) signal after connecting the ap cable.Another cable was used to troubleshoot and the same issue occurred.As a result, the pump was exchanged for another and the signal was clear.Therapy was continued without further complications to patient and case completed successfully.There was no report of patient complications or injury.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of iabp ap waveform missing is confirmed by a teleflex field service agent.A loosened cable connection between the fos and cpm boards was identified and retightened during service.A loosened cable connection between the fos and cpm board can cause a lack of communication between the boards, resulting in a failure of fos ap signal transmitting to the pump.The root cause of the complaint 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 reporting complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.

• Brand Name: AC3 OPTIMUS IABP NA/AJLA
• Type of Device: SYSTREM INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8850131
• MDR Text Key: 152914356
• Report Number: 3010532612-2019-00239
• Device Sequence Number: 1
• Product Code: DSP
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0701
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1