MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HCU 30

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

Further information regarding the repair of the device and investigation of the root cause has been requested.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint# (b)(4).The event occurred in (b)(6).It was reported that, during preventive maintenance, the device could not reach the specified temperature and displayed the error 1004 (main heater temp.Sensor error), due to faulty actuator [material #(b)(4)].

Event Description

Complaint number#: (b)(4).It was reported that the hcu 30 showed the error ¿1004 main heater temp.Sensor error¿.The device could not reach specified temperature, due to faulty actuator.

Manufacturer Narrative

It was reported that, during preventive maintenance, the hcu 30 showed the error ¿1004 main heater temp.Sensor error¿.The device could not reach specified temperature.On 2021-03-05 , the getinge field service technician (fst) confirmed the failure.The fst replaced the actuator 24v ac/dc 50/60hz (#70103.4052).All function test passed.The device is back in clinical use.Therefore, the most probable root cause for the failure "error 1004" is a defective actuator 24v ac/dc 50/60hz (material#: 70103.4052).The reported failure ¿error 1004¿ can be confirmed.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.

• Brand Name: HEATER COOLER UNIT
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11470437
• MDR Text Key: 241100672
• Report Number: 8010762-2021-00187
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HCU 30
• Device Catalogue Number: N/I
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/19/2021
• Patient Sequence Number: 1