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	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
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 was initiated as a result of the event.The device was discarded, but photos of the packaging containing a hair strand was provided to the supplier.The supplier determined that the production records and incoming inspection records contained no deviations.Root cause of the contamination could not be identified.One hundred percent visual inspection for package hair contamination has been impletmented as a control measure, but it will be possible that personnel fail to detect a hair strands.The supplier has included a hair contamination picture for reference within their procedural documentation.
Event or Problem Description
It was reported that a hair strand was found inside the sterile packaging of one of the silicone bile tubes.It was inside the second packet, attached to the tube.The device was used during a training case so it was not of concern from a patient perspective.
Additional Manufacturer Narrative
The device lot number was not provided.Thus, the device manufacture date could not be determined.
Event or Problem Description
It was reported that a hair strand was found inside the sterile packaging of one of the silicone bile tubes.It was inside the second packet, attached to the tube.The device was used during a training case so it was not of concern from a patient perspective.
Additional Manufacturer Narrative
The device lot number was determined to be 11112258.
Event or Problem Description
It was reported that a hair strand was found inside the sterile packaging of one of the silicone bile tubes.It was inside the second packet, attached to the tube.The device was used during a training case so it was not of concern from a patient perspective.

• Brand Name: ORGANOX METRA
• Common Device Name: NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR
• Manufacturer (Section D): ORGANOX LIMITED; 3500 john smith drive; oxford business park south; oxford, oxfordshire, gb OX4 2 WB; UK OX4 2WB
• Manufacturer (Section G): RAUMEDIC - MUENCHBERG; hermann-staudinger strasse 2; helmbrechts, bavaria, de 95233 ; GM 95233
• Manufacturer Contact: ruth colwill ; 3500 john smith drive; oxford business park south; oxford, oxfordshire, gb OX4 2-WB ; UK OX4 2WB
• MDR Report Key: 19307034
• Report Number: 3011560054-2024-00047
• Device Sequence Number: 17975090
• 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,Followup
• Report Date (Section B): 09/18/2024

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: 01/04/2022
• Device Catalogue Number: D0146
• Device Lot Number: 11112258
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 08/18/2022; 08/18/2022
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/26/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2021
• 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