ORGANOX METRA
Report
- Report Number
- 3011560054-2024-00063
- Event Type
- Malfunction
- Date Received
- July 2, 2024
- Date of Event
- June 3, 2024
- Report Date
- August 1, 2024
- Manufacturer
- ORGANOX LIMITED
- Product Code
- QQK
- PMA / PMN Number
- P200035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IT WAS CONFIRMED THAT THE LIVER WAS TRANSPLANTED SUCCESSFULLY.
CONFIRMATION IF ANY HEALTH EFFECTS OCCURRED AS A RESULT OF THE INCIDENT. IS PENDING. A SERVICE ENGINEER (SE) EVALUATED THE DEVICE AT THE CUSTOMER SITE. THE SYRINGE DRIVER WAS CLEANED AND LUBRICATED. AFTWARDS, THE SYRINGE DRIVER PASSED FUNCTIONAL TESTING.
THE DEVICE USER (DU) REPORTED HAVING A "BIT OF AN ISSUE WITH THE SYRINGE DRIVER THE OTHER NIGHT". SUBSEQUENTLY, IT WAS CONFIRMED THAT THE ISSUE EXPERIENCED BY THE DEVICE USER WAS THAT THE SYRINGE DRIVER BECAME STUCK. MESSAGE CODE 270 (SYRINGES NEED REPLACEMENT) DISPLAYED ON THE DEVICE WHEN THE EVENT OCCURRED. DU WAS ABLE TO CORRECT ISSUE TEMPORALLY BY RELEASING THE PIN AND RESETTING THE PLUNGER PLATE POSITION. THE SEIZED UP BLACK DIAL KNOB WAS THEN ABLE TO BE MOVED.
THE DEVICE USER REPORTED HAVING A "BIT OF AN ISSUE WITH THE SYRINGE DRIVER THE OTHER NIGHT". SUBSEQUENTLY, IT WAS CONFIRMED THAT THE ISSUE EXPERIENCED BY THE DEVICE USER WAS THAT THE SYRINGE DRIVER BECAME STUCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 800968 | ORGANOX METRA | NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR | QQK | ORGANOX LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |