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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 D0003
Device Problem Power Problem (3010)
Patient Problem Liver Damage/Dysfunction (1954)
Event Date 02/15/2024
Event Type  Injury  
Manufacturer Narrative
The device was returned to organox for complaint investigation.Root cause investigation is in progress.
 
Event Description
The device user (du) reached out to a clinical specialist (cs) stating "need support urgently.Device ac power delivery issue.Battery currently at 47% and no charge from wall".Troubleshooting was attempted and was unsuccessful.The cs recommended to remove the liver from the device, cold flush the liver, and then determine if donor liver is fit for transplantation.Du decided to perfuse the liver for as long as possible before conducting a cold flush.Following cold flush, the du decided to discard the liver.
 
Manufacturer Narrative
A service engineer (se) evaluated the device and determined that the power supply unit needed to be replaced.After the part was replaced, the device passed testing.
 
Event Description
The device user (du) reached out to a clinical specialist (cs) stating "need support urgently.Device ac power delivery issue.Battery currently at 47% and no charge from wall".Troubleshooting was attempted and was unsuccessful.The cs recommended to remove the liver from the device, cold flush the liver, and then determine if donor liver is fit for transplantation.Du decided to perfuse the liver for as long as possible before conducting a cold flush.Following cold flush, the du decided to discard the liver.
 
Manufacturer Narrative
Data from the perfusion case was downloaded and reviewed.The data review did not indicate any malfunction of the charging system or within the application of the device.An inspection of the power supply identified burned elements on the primary supply input stage.The power supply will be returned to the supplier and a scar will be requested.
 
Event Description
The device user (du) reached out to a clinical specialist (cs) stating "need support urgently.Device ac power delivery issue.Battery currently at 47% and no charge from wall".Troubleshooting was attempted and was unsuccessful.The cs recommended to remove the liver from the device, cold flush the liver, and then determine if donor liver is fit for transplantation.Du decided to perfuse the liver for as long as possible before conducting a cold flush.Following cold flush, the du decided to discard the liver.
 
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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
Manufacturer (Section G)
INTEGRATED TECHNOLOGIES LTD
viking house ellingham way
ashford, kent, gb TN23 6NF
UK   TN23 6NF
Manufacturer Contact
ruth colwill
oxford science park, magdalen
centre, robert robinson avenue
oxford, oxfordshire, gb OX4 4-GA
UK   OX4 4GA
MDR Report Key18916696
MDR Text Key337844304
Report Number3011560054-2024-00003
Device Sequence Number1
Product Code QQK
UDI-Device Identifier05060462240029
UDI-Public5060462240029
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P200035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 05/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberD0003
Device Catalogue NumberD0003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2024
Initial Date Manufacturer Received 02/15/2024
Initial Date FDA Received03/15/2024
Supplement Dates Manufacturer Received02/15/2024
02/15/2024
Supplement Dates FDA Received04/11/2024
05/10/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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