MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 701027652

Device Problems No Audible Alarm (1019); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was stated that during maintenance / service, after turned on the arterial pump "stop _ _" error message without audible alarm.No patient was involved.(b)(4).

Manufacturer Narrative

Field safety engineer has been sent for investigation.According to the service order no.(b)(4) he inspected and replaced the boards.Tested working ok.Performed function test and had pump running for several hours.Passed without any faults/errors.The replaced parts are not available for lab investigation.The failure could be confirmed.The most possible root cause could be determined as defective motor control board and control board.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5977807
• MDR Text Key: 55916881
• Report Number: 8010762-2016-00596
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701027652
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1