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

Model Number 70102.8718

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is being returned to the repair depot.A maquet field service technician will investigate the unit.A supplemental medwatch will be submitted as soon as additional information becomes available.

Event Description

It was reported that the ice block had filled the entire tank, indicating a bad ice sensor.No patient was involved, the malfunction was detected during maintenance / service.(b)(4).

Manufacturer Narrative

(b)(4).A maquet field service technician investigated the unit and replaced a shorted compressor and fan.A defective connector female 3/8" was also replaced.The unit was charged with freon.Preventive maintenance, functional test and safety check as per the service manual were performed successfully.

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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5398894
• MDR Text Key: 37714963
• Report Number: 8010762-2016-00052
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 05/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2005
• 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