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

Model Number D0003

Device Problem Failure to Charge (1085)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

Device data from the event was obtained and reviewed.The data review confirmed that the battery actually had a charge of about 96% at the time of the reported event.A corrective and preventive action (capa) has been iniitated to investigate this issue.The capa root cause investigation is pending completion.

Event Description

Device user (du) reported that message 80 was alarming.The device was charging and at 49%.It reached 50% at the time of troubleshooting.The device had been plugged in and the mains power switch was on.Du reset the display to confirm the correct percentage was displaying.The device continued to charge and message 80 went away at 51%.

• 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 Key: 19176641
• MDR Text Key: 341586105
• Report Number: 3011560054-2024-00030
• Device Sequence Number: 1
• Product Code: QQK
• UDI-Device Identifier: 05060462240005
• UDI-Public: 5060462240005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2024

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 Number: D0003
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1