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

Catalog Number D0146

Device Problems Failure to Read Input Signal (1581); Low Readings (2460)

Patient Problem Liver Damage/Dysfunction (1954)

Event Date 02/03/2024

Event Type  Injury  

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 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.

Event 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.

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.

• Brand Name: ORGANOX METRA
• Type of Device: 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
• MDR Text Key: 336741007
• Report Number: 3011560054-2024-00001
• Device Sequence Number: 1
• Product Code: QQK
• UDI-Device Identifier: 05060462240029
• UDI-Public: 5060462240029
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P200035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: D0146
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 02/03/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other