FDA Adverse Event
Malfunction
Summary report: N
ORGANOX METRA
MDR report key: 20025460
·
Received August 22, 2024
Report
- Report Number
- 3011560054-2024-00071
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- July 23, 2024
- Report Date
- August 21, 2024
- Manufacturer
- ORGANOX LIMITED
- Product Code
- QQK
- UDI-DI
- 05060462240005
- PMA / PMN Number
- P200035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A SERVICE ENGINEER (SE) EVALUATED THE DEVICE AT THE CUSTOMER SITE. A BATTERY DISCHARGE TEST WAS COMPLETED, AND THE DEVICE PASSED. ADDITIONALLY, A REVIEW OF THE EVENT DATA CONCLUDED THAT THE BATTERY DISCHARGE RATE WAS NORMAL.
Description of Event or Problem · 0
THE DEVICE USER (DU) REPORTED TO A SERVICE ENGINEER (SE) THAT THE DEVICE BATTERY WAS DISCHARGING FASTER DURING A RECENT CASE. SE PERFORMED A BATTERY DISCHARGE TEST TO ENSURE THE RATE OF DISCHARGE FOR THE BATTERY WAS WITHIN SPECIFICATIONS. THE SYSTEM PASSED THE BATTERY DISCHARGE TEST AND WAS ABLE TO STAY ON BATTERY POWER FOR LONGER THAN TWO HOURS DURING A TEST PERFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1118354 | ORGANOX METRA | NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR | QQK | ORGANOX LIMITED | 05060462240005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |