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

Model Number 70103.4642

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Patient Involvement (2645)

Event Date 12/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A maquet field service technician will investigate and repair the device.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

"no/low cooling capacity, no ice in the tank." the incident occurred during maintenance / service, no patient was involved.(b)(4).

Manufacturer Narrative

(b)(4).The device was investigated by the service engineer at the depot.He could not repair the device there, so it was returned to the manufacturing site.The compressor, the main heater, the potentiometer and the bottom cover were all replaced.Function and safety tests were carried out as per service protocols.All tests passed and the device was shipped back to the customer.The customer has confirmed that the unit is functioning properly and that there are no problems.There was no patient involvement.

Event Description

(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): 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: 5396623
• MDR Text Key: 37617835
• Report Number: 8010762-2016-00047
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70103.4642
• Device Catalogue Number: MCP00704631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2006
• 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