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

Model Number	D0146
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The device user reported visualizing a piece of hair in the cannula packaging.A clinical specialist informed the device user to use a new set of cannulas from a new disposable set so that the procedure could be completed.
Additional Manufacturer Narrative
The unopened cannula package was obtained from the customer.A supplier corrective action request (scar) was initiated and the unopened cannula package was sent to the supplier for root cause investigation.The supplier confirmed that a strand of hair was contained within the cannula packaging.Review of production records identified no deviations.The device was produced within clean room conditions.Staff is trained regularly regarding the "conduct in the medical area" procedure and they wear special cleanroom clothing including doble hairnets.The supplier performs 100% visual inspection prior to device release.Despite these controls being utilized the device packaging may be contaminated with a hair strand in rare instances and the hair may not be visible during inspection.The supplier has controls in place and those controls were utilized during production of the device.As a precaution the supplier will retrain staff on the "conduct in the medical area" process.Additionally, an effectiveness check will be completed with a specific focus on hair within the cannula packaging.
Event or Problem Description
The device user reported visualizing a piece of hair in the cannula packaging.A clinical specialist informed the device user to use a new set of cannulas from a new disposable set so that the procedure could be completed.

• 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 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: 18946471
• Report Number: 3011560054-2024-00004
• Device Sequence Number: 7348658
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2024
• Device Model Number: D0146
• Device Catalogue Number: D0146
• Device Lot Number: 11152743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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