FDA Adverse Event
Other
Summary report: N
SPECTRA OPTIA EXCHANGE SET
MDR report key: 2357607
·
Received November 23, 2011
Report
- Report Number
- 1722028-2011-00418
- Event Type
- Other
- Date Received
- November 23, 2011
- Date of Event
- June 21, 2011
- Report Date
- October 31, 2011
- Manufacturer
- CARDIANBCT
- Product Code
- LKN
- PMA / PMN Number
- K103090
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN PROGRESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
Description of Event or Problem · 1
AFTER CONNECTION, THE PT MENTIONED THAT HE WAS NOT FELLING WELL. HE COULD NOT EXACTLY DESCRIBE THE FEELING. PT ID IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE IS UNAVAILABLE FOR EVALUATION BECAUSE THE CUSTOMER DISCARDED THE SET. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFO PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION, MEDICAL INTERVENTION, OR POTENTIAL FOR SERIOUS INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTRA OPTIA EXCHANGE SET | SEPARATOR, AUTOMATED BLOOD CELL AND PL | LKN | CARDIANBCT | 05T3217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Other |