Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number ROTAFLOW
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 09/24/2020
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
During installation and testing an issue was found with the rotaflow drive.When the rpm are increased to more than 1000, the error message head error is displayed.(b)(4).
 
Manufacturer Narrative
The reported failure is part of the non conformance (b)(6) as the reported failure was discovered during installation and testing of the device.The rotaflow was not used for clinical application before.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
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10598414
MDR Text Key208966953
Report Number8010762-2020-00321
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 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
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 Received10/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-