FDA Adverse Event
Malfunction
Summary report: N
SPECTRA OPTIA COLLECT SET
MDR report key: 2113586
·
Received May 24, 2011
Report
- Report Number
- 1722028-2011-00164
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- April 21, 2011
- Report Date
- April 28, 2011
- Manufacturer
- CARIDIANBCT
- Product Code
- GKT
- PMA / PMN Number
- BK080035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CARIDIANBCT IS AWAITING FURTHER PHOTOS FROM THE CUSTOMER. INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.
Description of Event or Problem · 1
DURING A STEM CELL HARVEST PROCEDURE, THE CUSTOMER STATED THAT THEY NOTICED A DIFFERENT SOUND COMING FROM THE MACHINE. THE MACHINE SUDDENLY STOPPED AND THE SCREEN READ "TUBING SET RUPTURE/SPLIT IN THE CENTRIFUGE." THE CUSTOMER OPENED THE CENTRIFUGE DOOR AND DISCOVERED THE SET HAD SPLIT TWO HOURS INTO THE PROCEDURE, WITH BLOOD EVERYWHERE. NO INJURIES TO THE PT OCCURRED. THIS REPORT IS BEING FILED DUE TO THE SAFETY ALLEGATION OF POSSIBLE LOSS OF BLOOD. NO OTHER PT INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTRA OPTIA COLLECT SET | SEPARATOR, AUTOMATED, BLOOD CELL AND PL | GKT | CARIDIANBCT | 06S3103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |