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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 MCP00706291#ROTAFLOW PUMP MODULE
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2022
Event Type  malfunction  
Event Description
The event occurred in china.It was reported that during use the ac power of the rotaflow console (rfc) was automatically cut off.The rfc was switched automatically to the battery power.But the error message ¿bat.Err¿ was displayed.The customer was using the hand crank.After using the hand crank the patient's condition was normal and the patient was weaned off the machine.According to the getinge field service technician, the battery capacity was tested about 1 week before the event and the test found out that the battery could not be charged.Since the battery was charged continuously for more than 8.5 hours last time, the battery could not be maintained normally after the ac power was disconnected.Therefore, the battery voltage was not checked before this use, and the ac power supply was always used.No harm to any person has been reported.Complaint id: 721599.
 
Manufacturer Narrative
The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.
 
Manufacturer Narrative
The event occurred in china.It was reported that during use the ac power of the rotaflow console (rfc) was automatically cut off.The rfc was switched automatically to the battery power.But the error message ¿bat.Err¿ was displayed.The customer was using the hand crank.After using the hand crank the patient's condition was normal and the patient was weaned off the machine.According to the getinge field service technician, the battery capacity was tested about 1 week before the event and the test found out that the battery could not be charged.Since the battery was charged continuously for more than 8.5 hours last time, the battery could not be maintained normally after the ac power was disconnected.Therefore, the battery voltage was not checked before this use, and the ac power supply was always used.No harm to any person has been reported.The rotaflow console with s/n (b)(6) was investigated by a getinge field service technician and the reported failure could be confirmed.The rfc (rotaflow console) power supply board (article number 701011675) has been replaced.After the replacement the device is working as intended.An investigation of a rotaflow system that exhibited a similar issue "battery error" was performed in getinge life cycle engineering.The most probable root cause could be determined as a defective current measurement ic (ic2) on the power supply board.This provides an incorrect battery current signal.This signal interferes with the functioning of the microprocessor.Based on these investigation results the reported failure "bat.Err" could be confirmed.The review of the non-conformities was performed on 2022-11-16 and during the period of 2020-07-01 to 2022-11-16 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 affected rotaflow console in question was produced in 2020-07-01.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.
 
Event Description
Complaint id: (b)(4).
 
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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 Key15802959
MDR Text Key303749129
Report Number8010762-2022-00452
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 12/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMCP00706291#ROTAFLOW PUMP MODULE
Device Catalogue Number701046405
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2020
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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