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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 701022161 - ROTAFLOW DRIVE UNIT, BLUE
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/23/2020
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
Flow measurement is not displayed.(b)(4).
 
Manufacturer Narrative
When the reported failure "drive does not spin up" occurred is unknown.The device was directly involved and not able to meet its specifications.The failure could be confirmed.The affected rotaflow drive was sent back under rma#40952 for investigation/repair by the manufacturer emtec.Drive received in rastatt: 2020-06-04 functionality test in rastatt: 2020-06-18-->failure could be confirmed.Send to emtec: 2020-06-24 back from emtec: 2020-07-20 functionaltest after emtec: 2020-07-21.According to the service report rma2020-10223 dated on 2020-07-09 the reported failure"drive does not spin up" could be reproduced.No errors were shown on the console.Following work has been performed by emtec: -electronic party mc1 and mc2 have been replaced.-control cable has been replaced.-seal on bloack has been replaced.- rotaflow drive passed all tests.The most probable root cause could be determined according to emtec as aging.According to the service report 10478348 dated on 2020-07-21 the rotaflow drive was tested according to the current service protocol.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 Key10000401
MDR Text Key195949832
Report Number8010762-2020-00140
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,health professional
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number701022161 - ROTAFLOW DRIVE UNIT, BLUE
Device Catalogue Number701022161
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2020
Date Manufacturer Received07/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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