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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 701043290 - ROTAFLOW ENGLISH EU-PLUG
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up medwatch will be submitted when additional information becomes available.
 
Event Description
It was reported that the machine gives head error.As reported drive and unit were defective.Complaint number: (b)(4).
 
Manufacturer Narrative
The initial failure description was that the machine gives a head error on drive and unit.Both parts were affected.According to the service report from 2020-03-02 the field service technician was on site and checked the rotaflow drive and the rotaflow console.Both were detected as defective.The rotaflow control board and the rotaflow drive were replaced.Thus the reported failure "head error" could be confirmed.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 defective rotaflow drive was requested in rma#40663 on 2020-03-11 for technical investigation.This complaint will be closed as the most probable root cause for the reported failure are identified.If new relevant information becomes available after the investigation, this complaint will be reopened and necessary steps will be initiated.No information about the time of occurrence is available.No indication of actual or potential for harm or death.The device was directly involved in the incident.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
Complaintnumber: (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 Key9833134
MDR Text Key200422823
Report Number8010762-2020-00095
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number701043290 - ROTAFLOW ENGLISH EU-PLUG
Device Catalogue Number701043290
Date Manufacturer Received07/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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