MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 70104.4054

Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

August 20, 2015 10:05 am (gmt-4:00) added by (b)(6): a maquet field service technician investigated the unit and found the electric actuator of the hcu40 defective.The unit has been repaired and returned to service.A supplemental medwatch will be submitted as soon as additional information becomes available.(b)(4).

Event Description

The cardioplegia circuit draws air and showed the error message "cardioplegia circuit flow to low" then the unit stopped.The failure occurred during priming no patient was involved.

• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5018131
• MDR Text Key: 24597397
• Report Number: 8010762-2015-01003
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70104.4054
• Device Catalogue Number: 70104.4054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2015
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1