FDA Adverse Event
Malfunction
Summary report: N
PHOTOPHERESIS PROCEDURAL KIT; THERAKOS CELLEX
MDR report key: 1941628
·
Received December 20, 2010
Report
- Report Number
- 1941628
- Event Type
- Malfunction
- Date Received
- December 20, 2010
- Date of Event
- November 29, 2010
- Report Date
- December 20, 2010
- Manufacturer
- THERKOS, INC.
- Product Code
- LNR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
MULTIPLE COLLECTION PRESSURE ALARMS OCCURRED WHILE USING THE CELLEX INSTRUMENT. WE WERE UNABLE TO RESOLVE THE ALARMS EVEN WITH ADJUSTING THE COLLECTION RATE AND PRESSURE. A SHORT TIME AFTER THE UNRESOLVED ALARMS OCCURRED, A MASSIVE LEAK IN THE CENTRIFUGE AREA OCCURRED. THE DRIVE TUBE APPEARED TO BE FRACTURED. BLOOD WAS SPLASHED OVER THE ENTIRE CENTRIFUGE AREA. WHOLE BLOOD THAT WAS PROCESSED WAS WASTED. THE AMOUNT OF THE WASTE WAS 158ML. THE TREATMENT WAS ABORTED. THE PATIENT REMAINED STABLE AND NO INJURY WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHOTOPHERESIS PROCEDURAL KIT; THERAKOS CELLEX | PHOTOPHERESIS PROCEDURAL KIT; THERAKOS CELLEX | LNR | THERKOS, INC. | * | Y303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |