MAUDE Adverse Event Report: ORGANOX LIMITED ORGANOX METRA; NORMOTHERMIC MACHINE PERFUSION SYSTEM

Catalog Number	D0146
Medical Device Problem Codes	Failure to Read Input Signal (1581); Low Readings (2460)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	02/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Device user reported that the device failed to go into liver on board mode after a donor liver was placed on the device.As a result, the marginal liver was discarded.
Additional Manufacturer Narrative
Service engineer attended site and a service and full functional test was performed.All testing passed and no erratic behavior was seen in the pressure readings and no fault was found with the retained unit.The device data was collected and reviewed.Only the session data from 03 feb 2024 shows an unusual pressure reading and later an erratic random reading during the same perfusion.Device testing and data review suggests that the fault observed was with the disposable set used and not the retained unit.The customer had discarded the disposable set and therefore it is not possible to investigate for a root cause any further.
Additional Manufacturer Narrative
During troubleshooting the surgeon mentioned the device was reading -99mmhg.They adjusted tubing and refitted the sensor cable but the issue persisted.The arterial sensor appeared to have an unstable connection.Liver on board mode was achieved eventually, but the arterial pressure readings were irregular.Evaluation of the device is pending.
Event or Problem Description
Device user reported that the device failed to go into liver on board mode after a donor liver was placed on the device.As a result, the marginal liver was discarded.

• Brand Name: ORGANOX METRA
• Common Device Name: NORMOTHERMIC MACHINE PERFUSION SYSTEM
• 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): RAUMEDIC; hermann-staudinger strasse 2; helmbrechts bavaria, 48149 ; GM 48149
• Manufacturer Contact: ruth colwill ; oxford science park, magdalen; centre, robert robinson avenue; oxford, oxfordshire, gb OX4 4-GA ; UK OX4 4GA
• MDR Report Key: 18821974
• Report Number: 3011560054-2024-00001
• Device Sequence Number: 11893630
• Product Code: QQK
• UDI-Device Identifier: 05060462240029
• UDI-Public: 5060462240029
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: D0146
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2024
• Supplement Date Received by Manufacturer: 02/03/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown