MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MAQUET HCU 40; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HEATER COOLER UNIT

Device Problems Temperature Problem (3022); Excessive Heating (4030)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

(b)(4).It was reported that the heater temperature was too high.The circuits were overheated and stopped the system.

Manufacturer Narrative

During priming, the failure "heater temperature too high" occurred.According to the service report # (b)(4) dated 2019-10-25 the field service technician (fst) replaced the hcu 40 device printed circuit board, hcu 40 heater main hv kit, hcu 40 pump main wet end kit, hcu 40 main temp.Sensor for outlet, hcu 40 vacuum valve, hcu 40 hose clamp kit and hcu 40 filter mat.According to the communication with the sales and service unit (ssu) dated 2019-11-11 the probably root cause could be a defect of the heater.Thus the reported failure " heater temperature too high " could be confirmed.The reported failure heater temperature too high happened during priming.The hcu 40 which was used, was responsible for this complaint.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint no.(b)(4).

• Brand Name: MAQUET HCU 40
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9127375
• MDR Text Key: 196615655
• Report Number: 8010762-2019-00307
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/28/2019
• Patient Sequence Number: 1