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

Catalog Number	D0146
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as a part of a retrospective review and remediation effort based on enhancements made to the company's complaint handling processes.This event is being filed in accordance with a capa which has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.A supplier corrective action request (scar) was initiated for this device issue.The oxygenator was returned to the supplier for evaluation.Pictures and videos of the event were also sent to the supplier.Analysis of manufacturing records confirmed that the manufacture and release of the oxygenator was according to specifications.Review of complaints database revealed that one similar issue was reported for the lot in question.However, no concerning trend has been identified.Visual examination of the event video and pictures confirmed that blood leaked out of the gas escape port at the bottom of the oxygenator.The observed leakage pathway is typically correlated with the presence of a damaged capillary in the fibre bundle of the oxygenator module.The supplier indicated 100% of the oxygenators are subjected to final leak testing and that the oxygenator involved in the reported event successfully passed testing.The supplier indicated the oxygenator may have been exposed to stress post release during the sterilization process or during transport.Such stress could have contributed to the reported event.However, the root cause of the issue remains inconclusive.No specific action was currently deemed necessary.The supplier will continue to maintain and document periodic customer events monitoring in order to evaluate actions for products improvement.
Event or Problem Description
Device user (du) reported the device had a small leak at the oxygenator.A video of the leak and additional photos of the top of the oxygenator indicated that it was compromised.A clinical specialist (cs) advised the du to resolve the issue by changing the disposable set.

• Brand Name: ORGANOX METRA
• Common Device Name: 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): RAUMEDIC - MUENCHBERG; hermann-staudinger strasse 2; helmbrechts, bavaria, de 95233 ; GM 95233
• Manufacturer Contact: ruth colwill ; oxford science park, magdalen; centre, robert robinson avenue; oxford, oxfordshire, gb OX4 4-GA ; UK OX4 4GA
• MDR Report Key: 19320525
• Report Number: 3011560054-2024-00038
• Device Sequence Number: 7668863
• Product Code: QQK
• UDI-Device Identifier: 05060462240029
• UDI-Public: 5060462240029
• 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): 05/15/2024

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 Expiration Date: 01/31/2024
• Device Catalogue Number: D0146
• Device Lot Number: 11138738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown