MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU40; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HEATER-COOLER UNIT

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the hcu40 smells burnt.So the device was exchanged.During troubleshooting by the technician the heater of the patient circuit starts to smoke.When trying to drain the water out of the machine, the thermal switch caught fire.The technician turns the hcu off immediately and extinguishes the fire.There were no negative consequences to the patient.(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).(b)(6).The device was sent to rastatt for investigation and repair.According to the lce investigation report: there could have been a leak in the old main heater.(unfortunately, this is no longer reproducible, since the old main heater can no longer be installed and would no longer function), or the corrosion damage is caused by condensation that has formed around the thermal switch.The damage was due to a leak or condensation on the main heater.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.A supplemental medwatch will be submitted if new information has been received.

Event Description

Internal reference: (b)(4).Customer reference: (b)(4).

• Brand Name: MAQUET HCU40
• 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: 7142861
• MDR Text Key: 95761949
• Report Number: 8010762-2017-00408
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130300
• 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
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEATER-COOLER UNIT
• Device Catalogue Number: 701044054
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Date Device Manufactured: 06/01/2016
• 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