FDA Adverse Event
Other
Summary report: N
SPECTRA OPTIA EXCHANGE SET
MDR report key: 2092899
·
Received May 5, 2011
Report
- Report Number
- 1722028-2011-00102
- Event Type
- Other
- Date Received
- May 5, 2011
- Date of Event
- April 8, 2011
- Report Date
- April 8, 2011
- Manufacturer
- CARIDIANBCT
- Product Code
- LKN
- PMA / PMN Number
- K071079
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.
Description of Event or Problem · 1
CUSTOMER REPORTED MULTIPLE ALARMS AND PRESENCE OF AIR IN RETURN LINE. IT OCCURRED AT 1 HOUR INTO A THERAPEUTIC PLASMA EXCHANGE PROCEDURE. PT IDENTIFIER IS UNAVAILABLE AT THIS TIME. NO MEDICAL INTERVENTION WAS REQUIRED AND THE PT IS CURRENTLY STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTRA OPTIA EXCHANGE SET | SEPARATOR, AUTOMATED, BLOOD CELL AND PL | LKN | CARIDIANBCT | 03T3104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Other |