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

Model Number 701034642

Device Problems Device Emits Odor (1425); Smoking (1585); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A maquet field service technician will investigate the unit.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

"during use, it was noted that the popping sound was heard and smoke came out from the back of the hcu30.It smelled burnt as well.The customer continued to use the device, then the ice in the tank was gone.The display was showing the compressor was in operation, but no ice was being produced.No adverse effects on the patient." (b)(4).

Manufacturer Narrative

A maquet field service technician was on site and investigated the unit.The technician confirmed the reported issue and replaced the compressor.The failure was fixed due to replacing the compressor.The manufacturer has requested the defective part for further investigation.After the investigation results becomes available a supplemental medwatch will be submitted.

Event Description

(b)(4).

Manufacturer Narrative

A maquet field service technician was on site and investigated the unit.The technician confirmed the reported issue and replaced the compressor of the unit.The failure was fixed due to replacing the compressor.The manufacturer requested the defective part for further investigation.On 2016-06-03 the manufacturer received the defective compressor but the compressor is a purchased part, which is not repaired by maquet service.Therefore no investigation is possible.

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: 5548378
• MDR Text Key: 42516403
• Report Number: 8010762-2016-00244
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2016

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: 701034642
• Device Catalogue Number: 701034642
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/13/2016; 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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