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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM
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MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM Back to Search Results
Device Problems Failure To Adhere Or Bond (1031); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2012
Event Type  Injury  
Event Description
During a patient's treatment the sig symbol displayed, which is believed to be that past was not applied prior to the use.When the sig came on the perfusionist clamped the lines and applied paste.After applying the paste the abruptly placed the rotaflow disposable back into the drive which created an error message.The perfusionist attempted to shut the unit down and re-boot but apparently forgot all of the steps so the rpm's would not ramp up.The perfusionist then decided to use the hand crank and called for assistance from another perfusionist.This perfusionist quickly came in and started the rotaflow without incident.The perfusionist on the case admitted that he had forgotten all of the steps to restart the unit after shutting it down.Please note that every perfusionist on the team has been trained and signed off on the rotaflow training document.There were no efforts to the patient.(b)(4).
 
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Brand Name
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
MDR Report Key4365165
MDR Text Key15910732
Report Number3008355164-2014-00309
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/11/2014,11/29/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/29/2012
Event Location Hospital
Date Report to Manufacturer11/29/2012
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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