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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 Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2020
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
Speed, flow, and status displays were off during treatment.Pump stopped.The medical staff used the emergency drive and rotaflow device has been exchanged.No person was harmed.Complaint id: (b)(4).
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
The reported failure "display not working" was discovered during patient treatment at the shenzhen people's hospital.The device was directly involved in the incident and not able to meet its specifications.The failure could be confirmed.According to the service report dated on the 2020-06-17 a getinge service technician confirmed that the display was not working.The 70103.4051 rfc control board kit (serial number (b)(4)) has been replaced.After replacement the rotaflow was working normally.The reported failure "display not working" was already investigated by the life-cycle-engineering (lce) in complaint (b)(4).In reference to lce report (b)(4) dated on 2018-03-29.In the investigation the failure could be confirmed.The flash memory module ic 8 was found to be temperature dependent.When cooling the flash memory module ic 8 the malfunction disappeared.At room temperature the display did not work again.After replacing the flash memory module ic 8 the rotaflow console worked normally again.The most probable root cause could be determined as: a defective flash memory module (ic8).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.
 
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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 Key10168916
MDR Text Key198680685
Report Number8010762-2020-00206
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 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROTAFLOW
Device Catalogue Number70104.6405
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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