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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 Communication or Transmission Problem (2896)
Patient Problems No Information (3190); Insufficient Information (4580)
Event Date 11/27/2020
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 ¿error stop-inp¿.(b)(4).
 
Manufacturer Narrative
The initial failure description was that the rotaflow displays the error message "stop-inp".The affected rotaflow console (with the serial number (b)(6) and the rotaflow drive (with the serial number (b)(6)) were sent back to the manufacturer for repair.The device was received on 2021-03-10 and during the investigation by the service department on 2021-03-18 the reported failure "stop-inp" could be reproduced.The 70103.4051 rfc control board kit has been replaced has been replaced by the service department.After functional test at getinge service department on 2021-03-19 the device was sent back to the user.An investigation of a rotaflow system that exhibited a similar issue was performed in getinge life cycle engineering on 2020-04-27.The most probable cause of the described error is a defect on the micro controller ic23 on the control board that worsens when the device gets warm.A device history review (dhr) was performed and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.Based on these investigation results the reported failure could be confirmed.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 Key10957701
MDR Text Key219890756
Report Number8010762-2020-00421
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
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROTAFLOW
Device Catalogue Number701022161
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2021
Date Manufacturer Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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