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

Catalog Number D0003

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

A service engineer (se) evaluated the device at the customer site.The se removed, disassembled, and cleaned the arterial pinch valve.Afterwards, it was reinstalled.Multiple stress tests were completed successfully.It was confirmed that there was no fluid flowing through while the valve was closed at 100%.Although the device passed testing, it was decided to return the device to the manufacturer for further evaluation.Once returned to the manufacturer, the motor controller board (mcb) was replaced as a precaution.After the mcb was replaced the device once again passed testing successfully.

Event Description

It was reported that the arterial pinch valve was reading as 100% closed with fluid clearly passing by.The arterial pressure reading was about 65mmhg at the time of the event.A stop and restart was performed with observation of the arterial pinch valve moving, but not fully occluding the tubing to a desired level.

Event Description

It was reported that the arterial pinch valve was reading as 100% closed with fluid clearly passing by.The arterial pressure reading was about 65mmhg at the time of the event.A stop and restart was performed with observation of the arterial pinch valve moving, but not fully occluding the tubing to a desired level.

Manufacturer Narrative

The return date of the device for evaluation was april 12.2024.

• 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: 19208996
• MDR Text Key: 341815597
• Report Number: 3011560054-2024-00041
• Device Sequence Number: 1
• Product Code: QQK
• 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,Followup
• Report Date: 04/29/2024

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 Catalogue Number: D0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• 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