MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 70102.8718

Device Problems No Display/Image (1183); Loss of Power (1475)

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

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

September 17, 2015 08:59 am (gmt-4:00) added by (b)(6): (b)(4).A maquet field service technician evaluated the unit and determined the wiring was in need of replacement on the lower power supply.As a precaution the 20 amp breaker was also replaced.The unit passed testing to factory specifications.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

It was reported that during a case the unit shut down and the screen went blank.The system was not removed because this happened at the very end of the case.The decision was made it would be best to keep the temperature of the water as it was, rather than start a new system and go through warming process.No reported patient effect.(b)(4).

• Brand Name: MAQUET HCU30 DEVICE
• 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: 5084976
• MDR Text Key: 26385852
• Report Number: 8010762-2015-01049
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/21/2015

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 Model Number: 70102.8718
• Device Catalogue Number: 70102.8718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2005
• 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