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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HCU 30
Device Problem Insufficient Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2022
Event Type  malfunction  
Event Description
It was reported that all the ice of the hcu 30 melted and the temperature of the circulating water on the cardioplegia side stopped decreasing.The failure occurred during surgery.The surgery was continued by replacing the unit with another heater cooler unit.No harm to any person has been reported.Complaint id: (b)(4).
 
Manufacturer Narrative
Further investigation is on-going.A follow-up medwatch will be submitted when additional information becomes available.Further information has been requested but has not yet been received.
 
Manufacturer Narrative
It was reported that all the ice of the hcu 30 melted and the temperature of the circulating water on the cardioplegia side stopped decreasing.The failure occurred during surgery.The surgery was continued by replacing the unit with another heater cooler unit.No harm to any person has been reported.A getinge field service technician (fst) investigated the affected device upon an in-house verification.The fst confirmed that the temperature on the cardioplegia side did not decrease.On closer inspection, it was found that the actuator on the cardioplegia side was not working properly.After replacement of the hcu 30 actuator 24v ac/dc 50/60hz (material #701034052) the issue was rectified.Further, the actuator on the main side was preventivly replaced.Afterwards, the valves of the device were cleaned.Lastly, the device was tested and found working as intended.The device is back in clinical use.According to the hcu 30 service manual (hcu 30 | service manual | english | 07| hcu 30 | 9 troubleshooting | 110 |) when the temperature regulation works poorly or not at all and/or the cooling capacity is poor a possible cause for the failure is a defective 3-way valve actuator.The hcu 30 actuator operates the 3-way valve to adjust the water temperature of the device.Therefore, the most probable root cause for the reported failure is a defective 3-way valve actuator due to ageing.The hcu 30 has been phased out since the end of 2010.The technical support, in-house repairs, as well as spare parts supplies have been discontinued in 2017.The review of the non-conformities has been performed on 2022-09-26 for the period of 2016-05-10 to 2022-06-21.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely to have contributed to the reported failure.The product in question was produced in 2016-05-10.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.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.
 
Event Description
Complaint id: (b)(4).
 
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Brand Name
HEATER COOLER UNIT
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
neue rottenburger strasse 37
hechingen
Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key14776843
MDR Text Key301836829
Report Number8010762-2022-00238
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K031544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 09/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHCU 30
Device Catalogue Number70102.8718
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2016
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexPrefer Not To Disclose
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