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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 Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2024
Event Type  malfunction  
Manufacturer Narrative
The device was evaluated by a service engineer.They determined that the usb connector was only partially connected to the oxygen consentrator.The cable was re-seated.Afterwards, the device was tested and functioned according to specification.
 
Event Description
Device user (du) reported that message code 470 (oxygen concentrator failure) was present and requested a call for support.A clinical specialist (cs) called the du and was informed the disposable set was fully primed, no liver on board, and that the du was currently performing a power cycle.Cs assisted in placing the terumo back into operate mode and initiating preparation mode.Message code 470 appeared shortly after entering preparation mode.A stop/start with a 10 second wait period was attempted with no success.Cs advised the du to use a different metra retained unit.The primed disposable set was transferred to this device with no issues.The du confirmed that preparation mode was able to proceed with no issues.
 
Manufacturer Narrative
The device was not returned to the manufacturer.It was actually evaluated at the customer site.An assessment is pending to determine if the device issue warrants initiation of a corrective and preventive action (capa).
 
Event Description
Device user (du) reported that message code 470 (oxygen concentrator failure) was present and requested a call for support.A clinical specialist (cs) called the du and was informed the disposable set was fully primed, no liver on board, and that the du was currently performing a power cycle.Cs assisted in placing the terumo back into operate mode and initiating preparation mode.Message code 470 appeared shortly after entering preparation mode.A stop/start with a 10 second wait period was attempted with no success.Cs advised the du to use a different metra retained unit.The primed disposable set was transferred to this device with no issues.The du confirmed that preparation mode was able to proceed with no issues.
 
Manufacturer Narrative
A capa has been initiated in order to investigate the cause of the usb connector becoming loose.Root cause determination is pending.
 
Event Description
Device user (du) reported that message code 470 (oxygen concentrator failure) was present and requested a call for support.A clinical specialist (cs) called the du and was informed the disposable set was fully primed, no liver on board, and that the du was currently performing a power cycle.Cs assisted in placing the terumo back into operate mode and initiating preparation mode.Message code 470 appeared shortly after entering preparation mode.A stop/start with a 10 second wait period was attempted with no success.Cs advised the du to use a different metra retained unit.The primed disposable set was transferred to this device with no issues.The du confirmed that preparation mode was able to proceed with no issues.
 
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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 Key19040733
MDR Text Key340125354
Report Number3011560054-2024-00015
Device Sequence Number1
Product Code QQK
UDI-Device Identifier05060462240005
UDI-Public5060462240005
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
Report Date 04/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberD0003
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/05/2024
Initial Date Manufacturer Received 03/05/2024
Initial Date FDA Received04/04/2024
Supplement Dates Manufacturer Received03/05/2024
Supplement Dates FDA Received04/30/2024
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
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