Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HCU 30
Device Problem Excessive Cooling (2932)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2021
Event Type  malfunction  
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.
 
Event Description
It was reported that the all the ice of the hcu 30 melted and the temperature of the circulating water could not be lowered.The failure occurred during surgery.Before surgery the ice inside of the tank was checked and found that the ice had formed normally at that time.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
It was reported that the all the ice of the hcu 30 melted and the temperature of the circulating water could not be lowered.The failure occurred during surgery.Before surgery the ice inside of the tank was checked and found that the ice had formed normally at that time.The surgery was continued by replacing the unit with another heater cooler unit.No harm to any person has been reported.The device was inspected by a getinge field service technician and the failure could not be reproduced.The device was working as intended.The customer confirmed that the affected hcu 30 is to be disposed of and is therefore no longer in clinical use.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.However, according to the hcu 30 service manual (hcu 30 | service manual | english | 07| hcu 30 | 9 troubleshooting | 110) if the ice melts, a possible cause of the failure is a shunt valve that does not close properly.The review of the non-conformities has been performed on 2022-04-08 for the period of 2009-12-22 to 2022-02-22.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 2009-12-22.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.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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13708503
MDR Text Key286842939
Report Number8010762-2022-00073
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHCU 30
Device Catalogue Number701034642
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2009
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexPrefer Not To Disclose
-
-