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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
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
It was reported that the rotaflow displays the error message "head error".(b)(4).
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
The reported failure "head error" occurred during preventative maintenance.The affected drive with s/n (b)(6) will be send back to supplier for repair.The following most possible root cause could be determined for the head error: the head error is caused by the hot plug.When the device is in operation and the power plug is plugged in or out the head error occurs and the rota flow drive and / or the control board is damaged.As a result the rota flow drive and / or the control board has to be replaced.The product in question was produced in 2012-02-06.The review of the non-conformities during the period of 2012-02-06 to 2021-02-24 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 can be excluded.Based on these investigation results the reported failure could be confirmed.In order to avoid reoccurrence of the reported failure, the user will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.2 | en | v13.Chapter 4.1.3: switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.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.
 
Manufacturer Narrative
The reported failure "head error" occurred during preventative maintenance.The affected drive with s/n (b)(6) will be send back to supplier for repair.The following most possible root cause could be determined for the head error: the head error is caused by the hot plug.When the device is in operation and the power plug is plugged in or out the head error occurs and the rota flow drive and / or the control board is damaged.As a result the rota flow drive and / or the control board has to be replaced.The product in question was produced in 2012-02-06.The review of the non-conformities during the period of 2012-02-06 to 2021-02-24 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 can be excluded.Based on these investigation results the reported failure could be confirmed.In order to avoid reoccurrence of the reported failure, the user will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.2 | en | v13.Chapter 4.1.3: switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.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
MDR Report Key11116094
MDR Text Key225723972
Report Number8010762-2021-00004
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
PMA/PMN Number
K991864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Type of Report Initial,Followup,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROTAFLOW
Device Catalogue Number70102.2161
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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