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

Model Number ROC 20-151

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was stated that the cardioplegia level sensor was not functioning.No known consequences to patient.(b)(4).

Manufacturer Narrative

Service technician was unable to duplicate reported failure.He tested level sensor, checked integrity of connectors, ensured proper seating of level module.He performed full functional check and safety test and returned unit to clinical service.No parts were replaced therefore no laboratory investigation is performed.Similar failure with similar malfunction has been investigated in the life cycle engineering before as follows: according to investigation report by (b)(4), the error "sensor fault" (displayed on the scp) could be reproduced.Most probable root cause could be determined as a defective transistor, which disturbed the current supply of the level sensor.The module has to be replaced and it is highly recommended to check or replace the level sensor as it can have been damaged by too high voltage.Thus the failure could be confirmed.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

Internal reference: (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: 7171905
• MDR Text Key: 96814257
• Report Number: 8010762-2018-00007
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROC 20-151
• Device Catalogue Number: MCP0702877
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Date Device Manufactured: 01/01/2006
• 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