FDA Adverse Event
Injury
Summary report: N
CADD-TPN
MDR report key: 19363
·
Received February 2, 1995
Report
- Report Number
- MW1004967
- Event Type
- Injury
- Date Received
- February 2, 1995
- Report Date
- January 23, 1995
- Manufacturer
- SIMS DELTEC, INC.
- Product Code
- FRN
- Report Source
- Voluntary report
- Reporter Location
- AK, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PT RECEIVES THERAPY THROUGH PUMP DAILY. ON 12/29/94, 800 ML WAS INFUSED AND PUMP REGISTERED 30 ML REMAINING, BUT BAG WAS EMPTY. ON 1/13/95, AFTER CHANGING PROCEDURE AND WEIGHING ALL FILLED BAGS, PT'S BAG, AFTER PUMP REGISTERED 800 ML INFUSED, STILL HAD 264 ML MEASURED QUANTITY IN RESERVOIR BAG. PUMP RETURNED TO PHARMACY. UPON TESTING, ERROR CODE "99" APPEARED, MEANING PUMP MOTOR FAILURE. PUMP IS CURRENTLY BEING REPAIRED BY MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CADD-TPN | HOME INFUSION DEVICE | FRN | SIMS DELTEC, INC. | 5700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |