MAUDE Adverse Event Report: ORGANOX LIMITED ORGANOX METRA; NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR

Catalog Number	D0003
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the case the device user (du) had to recalibrate the metra four times.It was noted that there were significant discrepancies in po2 levels when compared to their lab machine.
Additional Manufacturer Narrative
A service engineer (se) evaluated the device at the customer site.The se cleaned the probe head and verified units of measurements.All units were in mmhg.The se verified calibrations on multiple calibrators.No problems were observed.The se tested the system throughout a range of po2 and pco2 values and verified the system responded appropriately in o2 and air outputs changes.The se performed perfusion for 20 minutes with no issues observed.A clinical specialist (cs) also visited the customer site.The cs observed device user's (du) manual calibration process.The cs identified the du performed manual calibration incorrectly.During the manual calibration process, the du is supposed to press "store" on the terumo simultaneous to the abg draw that is then tested externally for comparison.However, the du pressed "store" upon returning with the abg result which was about five minutes after the sample draw.This means that the manual calibration was being adjusted based on two separate data points of time and not a single data point.While this does not explain the initial deviation experienced following the standard calibration of the shunt sensor, it is suspected that user error contributed both to the increased margin of error of the deviation and the increased need for repeated manual calibrations reported.

• Brand Name: ORGANOX METRA
• Common Device Name: NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR
• Manufacturer (Section D): ORGANOX LIMITED; 3500 john smith drive; oxford business park south; oxford, oxfordshire, gb OX4 2 WB; UK OX4 2WB
• Manufacturer (Section G): INTEGRATED TECHNOLOGIES LTD; viking house; ellingham way; ashford, kent, gb TN23 6NF; UK TN23 6NF
• Manufacturer Contact: ruth colwill ; 3500 john smith drive; oxford business park south; oxford, oxfordshire, gb OX4 2-WB ; UK OX4 2WB
• MDR Report Key: 20417020
• Report Number: 3011560054-2024-00089
• Device Sequence Number: 12812699
• Product Code: QQK
• UDI-Device Identifier: 05060462240005
• UDI-Public: 5060462240005
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P200035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: D0003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown