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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number ROTAFLOW CHINESE ZH-PLUG
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2023
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing.Further information has been requested but has not yet been received.A follow up will be submitted when additional information becomes available.
 
Event Description
The customer reported that after 30 minutes in use the rotaflow displayed the error message ¿sig¿.After reapplying the flow sensor cream the rotaflow reported sig again.After three consecutive times, the user decided to replace the rotaflow drive and the use was normal.No harm to any person has been reported.Complaint id: (b)(4).
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
The customer reported that after 30 minutes in use the rotaflow displayed the error message ¿sig¿.After reapplying the flow sensor cream the rotaflow reported sig again.After three consecutive times, the user decided to replace the rotaflow drive and the use was normal.No harm to any person has been reported.The rotaflow drive (rfd) with s/n (b)(6) was sent back to manufacturer for repair.During the investigation by the getinge service department on 2023-06-12 the reported "sig error" could be confirmed.The rf drive closing cover kit (article number 70101.1680) has been replaced.The closing cover kit was replaced as the rubber bumper of the closing assy was missing.The rubber bumper must have come loose at customers site, as we have not found any other complaint of the affected rfd with the reported failure.After functional test at the getinge service department on 2023-06-12 the device was sent back to the user.The most probable root cause could be determined as the rubber pumper of the closing assy was missing which could lead to the reported "sig error".Based on these investigation results the reported failure "sig error" could be confirmed.The rotaflow console in question was produced in 2020-11-05.The review of the non-conformities was performed on 2023-01-18 and during the period of 2020-11-05 to 2023-01-18 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.The customer will be informed about the results by getinge sales and service unit.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.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
HEART LUNG MACHINE
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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 Key16231709
MDR Text Key307982228
Report Number8010762-2023-00035
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K991864
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,Followup
Report Date 06/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROTAFLOW CHINESE ZH-PLUG
Device Catalogue Number701046405
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2020
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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