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	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
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.The du indicated the device was discarded, thus could not be returned.Photos of the packaging were obtained and forwarded to the device supplier.A supplier corrective action request (scar) was initiated.The supplier was unable to confirm the presence of a hole in the packaging from viewing the photos provided, but indicated maybe there was a crack in the packaging.Review of production records found no deviations.No root cause could be identified.As a precaution, the supplier will update their procedure to clarify all components and their packaging are to be free of damage.
Event or Problem Description
Device user (du) reported that there was a small hole on the plastic side of the vascular cannulas packaging.As aresult, the items were deemed unsterile and another another kit was opened.

• 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: 19323793
• Report Number: 3011560054-2024-00044
• Device Sequence Number: 17765591
• 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: 06/17/2024
• Device Catalogue Number: D0146
• Device Lot Number: 11143399
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2023
• 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