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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 MCP00706033#ROTAFLOW JAPANESE US-PLUG
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2022
Event Type  malfunction  
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.
 
Event Description
The event occurred in japan.It was reported that the error message ¿sig error¿ occurred about 12 hours after the rotaflow was started in clinical use.The hospital decided not to reapply the flow sensor cream and switch to another rotaflow.No harm to any person has been reported.Complaint id: (b)(4).
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
The event occurred in japan.It was reported that the error message ¿sig error¿ occurred about 12 hours after the rotaflow was started in clinical use.The hospital decided not to reapply the flow sensor cream and switch to another rotaflow.No harm to any person has been reported.The affected rotaflow console with s/n (b)(6) and the rotaflow drive with s/n (b)(6) were investigated by a getinge field service technician.The technician was unable to confirm the reported "sig error".The technician advised the customer to follow the instruction for use to avaid the "sig error".The unit was tested and is back in use.Based on these investigation results the reported failure "sig error" could not be confirmed.However, the failure mode "sig error" can be linked to the following most possible root causes according to our risk management file (dms# (b)(4)): dried contact gel.User forgot renewing contact gel.Rotaflow console s/n (b)(6): the review of the non-conformities was performed on 2022-12-19 and during the period of 2017-09-16 to 2022-12-19 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 rotaflow console in question was produced in 2017-09-16.Rotaflow drive s/n (b)(6): the review of the non-conformities was performed on 2023-01-30 and during the period of 2017-09-16 to 2023-01-30 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 rotaflow drive in question was produced in 2017-09-16.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | 15.6.2 reapplying ultrasonic contact cream.The ultrasonic contact cream can dry out and impair the functioning of the integrated flow/bubble sensor.In the "free" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message [sig!] appears.In the "stand al" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message [faultbub] appears.The error message [sig!] indicates an error in the integrated flow/bubble sensor, which may result in an incorrect flow display.The rotaflow centrifugal pump still continues to function.If the error occurs during lpm mode, the rotaflow system switches back to rpm mode automatically.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 Key16004056
MDR Text Key306687480
Report Number8010762-2022-00506
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
Reporter Country CodeJA
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 01/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMCP00706033#ROTAFLOW JAPANESE US-PLUG
Device Catalogue Number701043297
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2017
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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