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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORGANOX LIMITED ORGANOX METRA; NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR
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ORGANOX LIMITED ORGANOX METRA; NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR Back to Search Results
Model Number D0146
Device Problem Fluid/Blood Leak (1250)
Patient Problem Liver Damage/Dysfunction (1954)
Event Date 12/18/2023
Event Type  Injury  
Event Description
A liver was placed on the device.The device user contacted a clinical specialist (cs) subsequently because a leak was observed underneath the liver bowl approximately 20 minutes into the perfusion.The cs advised the device user to put bone wax over the area and replace zip tie on the connection, but this was unsuccessful.All the blood leaked out of the pump onto the device.Attempt to cold flush the liver was unsuccessful.Device user alleged that the device failed.Liver was discarded.
 
Manufacturer Narrative
Report number (b)(4) submitted to fda by initial reporter.Additionally, it has been confirmed that the event date is actually 18dec2023, not 17dec2023.
 
Manufacturer Narrative
A service engineer (se) evaluated the device.It was determined that the leak resulted from damage to the ascites port spigot on the liver bowl which is believed to have been caused by impact damage prior to the device being delivered to the customer.A supplier corrective action request (scar) has been requested to investigate further.
 
Event Description
A liver was placed on the device.The device user contacted a clinical specialist (cs) subsequently because a leak was observed underneath the liver bowl approximately 20 minutes into the perfusion.The cs advised the device user to put bone wax over the area and replace zip tie on the connection, but this was unsuccessful.All the blood leaked out of the pump onto the device.Attempt to cold flush the liver was unsuccessful.Device user alleged that the device failed.Liver was discarded.
 
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Brand Name
ORGANOX METRA
Type of Device
NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR
Manufacturer (Section D)
ORGANOX LIMITED
oxford science park, magdalen
centre, robert robinson avenue
oxford, oxfordshire, gb OX4 4 GA
UK  OX4 4GA
MDR Report Key18894325
MDR Text Key337548167
Report Number3022300078-2024-00001
Device Sequence Number1
Product Code QQK
UDI-Device Identifier05060462240029
UDI-Public5060462240029
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/13/2024,04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberD0146
Device Lot Number11148086
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/13/2024
Distributor Facility Aware Date12/18/2023
Device Age7 MO
Event Location Hospital
Date Report to Manufacturer12/18/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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