FDA Adverse Event
Injury
Summary report: N
CADD MEDICATION CASSETTE RESERVOIR
MDR report key: 2121368
·
Received June 6, 2011
Report
- Report Number
- 2183502-2011-00456
- Event Type
- Injury
- Date Received
- June 6, 2011
- Report Date
- June 3, 2011
- Manufacturer
- SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
- Product Code
- FRN
- PMA / PMN Number
- K843772
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. INVESTIGATION DETERMINED THAT THE RETURNED SAMPLE MET MFG REQUIREMENTS FOR THIS PRODUCT. THE DEVICE PASSED FUNCTIONAL TESTING.
Description of Event or Problem · 1
DISTRIBUTOR REPORTED THAT A HOMECARE PT WAS RECEIVING AN INFUSION. ACCORDING TO THE REPORTER, THE PT LOST CONSCIOUSNESS. EMERGENCY SERVICES WERE CONTACTED. NO TREATMENT WAS GIVEN UPON ARRIVAL. ACCORDING TO THE REPORTER, THE PRODUCT WAS FOUND TO BE LEAKING. NO PERMANENT ADVERSE EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CADD MEDICATION CASSETTE RESERVOIR | FRN - AMBULATORY PUMP DISPOSABLE | FRN | SMITHS MEDICAL MD (FORMERLY DELTEC, INC) | 21-7002 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |