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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT HCU30; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT HCU30; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HCU 30
Device Problem Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2023
Event Type  malfunction  
Event Description
It was reported that the hcu30 main side temperature does not rise with displaying the error ¿1004-2¿.The failure occurred during patient treatment.The patient treatment 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
It was reported that the hcu30 main side temperature does not rise with displaying the error ¿1004-2¿.The failure occurred during patient treatment.The patient treatment 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) was sent for investigation und could confirme the reported failure.The fst confirmed that the issue will be resolved after cleaning the 3-way valve and the shunt valve.A similar component "3 way valve" was already investigated in complaint with life cycle engineering (lce) investigation: the valves can be blocked by particles, which cause a permanent leakage to the tank.Furthermore, a similar component "3 way valve" was also investigated in complaint with life cycle engineering (lce): the most probable root cause could be found by the massive deposits: if the hcu 30 was switched off while the three-way valve was in the open position (means cooling process) it is possible that, after an indefinite period of time, the deposits stuck the valve in this position so that the spring didn¿t have enough power to close the valve when the device was put into operation again.Therefore, the most probable root cause for the failure ¿hcu30 main side temperature does not rise with displaying the error ¿1004-2¿¿ is a blocked 3-way valve and shunt valve.Furthermore, with reference to the hcu 30 service manual (v07) for the failure "hcu30 main side temperature does not rise with displaying the error ¿1004-2¿", different causes are possible, such as a defective 3-way-valve or a defective actuator.Furthermore, this failure may cause the error message ¿1004-2¿.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 2024-02-01 for the period of 2011-08-22 to 2023-12-22.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 2011-08-22.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.
 
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Brand Name
HEATER COOLER UNIT HCU30
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 Key18649182
MDR Text Key334625828
Report Number8010762-2024-00073
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
Type of Report Initial
Report Date 02/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHCU 30
Device Catalogue Number701028718
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2024
Initial Date FDA Received02/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2011
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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