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

Catalog Number	D0003
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A service engineer (se) reviewed the case data and confirmed the battery decrease reported.Subsequently, a se evaluated the device at the customer site.The se identified significant heat damage within the battery compartment, thus the device was returned to the manufacturer for further evaluation and repair.The customer was given a replacement device.Additional evaluation of the device involved in the reported event concluded the batteries had shifted within the bracket designed to keep the batteries stationary.The batteries shifted horizontally towards the center of the device.This movement seems to have caused battery circuit connection issues with the device.This is believed to be a result of severe jarring that could be associated with machine shipping, transportation, or movement throughout the hospital.A corrective action preventive action (capa) has been initiated to further investigate the issue.Additionally, a design change is in process to address the issue.
Event or Problem Description
The device user (du) reported that the device battery was at 48 percent and message 80 (low battery) was present.The du said that the device was only unplugged for roughly 10 to 15 minutes.They mentioned that they did not notice a sudden drop in battery percentage and did not notice the low battery until it was alarming.The customer had moved the device to a sub sterile room in the operating room (or) for a while, but the device was plugged in and the green mains power switch was on.Once the device was in the recipient or, the du noticed the device was charging when using that outlet.The du was instructed to test the outlet in the sub sterile room with other equipment and it was noted that the outlet worked.The du was also asked to test the outlet in the sub sterile room with the device after the liver was taken off.The du confirmed that the device was plugged in and charging at its storage location.
Additional Manufacturer Narrative
The root cause of this issue was determined to be due to the retention bracket not retaining the battery when jarring or transport impact occurs.The correction involves placing two cable ties around each battery pack to provide additional securement to the frame of the device.This correction will be conducted by organox field service engineers.
Event or Problem Description
The device user (du) reported that the device battery was at 48 percent and message 80 (low battery) was present.The du said that the device was only unplugged for roughly 10 to 15 minutes.They mentioned that they did not notice a sudden drop in battery percentage and did not notice the low battery until it was alarming.The customer had moved the device to a sub sterile room in the operating room (or) for a while, but the device was plugged in and the green mains power switch was on.Once the device was in the recipient or, the du noticed the device was charging when using that outlet.The du was instructed to test the outlet in the sub sterile room with other equipment and it was noted that the outlet worked.The du was also asked to test the outlet in the sub sterile room with the device after the liver was taken off.The du confirmed that the device was plugged in and charging at its storage location.

• 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): INTEGRATED TECHNOLOGIES LTD; viking house; ellingham way; ashford, kent, gb TN23 6NF; UK TN23 6NF
• Manufacturer Contact: ruth colwill ; 3500 john smith drive; oxford business park south; oxford, oxfordshire, gb OX4 2-WB ; UK OX4 2WB
• MDR Report Key: 20305742
• Report Number: 3011560054-2024-00085
• Device Sequence Number: 18363690
• Product Code: QQK
• UDI-Device Identifier: 05060462240005
• UDI-Public: 5060462240005
• 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
• Remedial Action: Modification/Adjustment,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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 Catalogue Number: D0003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3011560054/10152024/C/00
• Patient Sequence Number: 1
• Patient Sex: Unknown