FDA Adverse Event
Malfunction
Summary report: N
CADD LEGACY PLUS
MDR report key: 2234317
·
Received August 15, 2011
Report
- Report Number
- MW5021960
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Date of Event
- August 15, 2011
- Report Date
- August 15, 2011
- Manufacturer
- SMITHS MEDICAL MD, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PT WAS PRESCRIBED A 5-FLUOROURACIL VIA CADD PUMP 4600 MG PER 96 ML AT 1ML PER HOUR FOR 96 HRS. PT RETURNED TO CLINIC; CASSETTE WAS EMPTY 9 HOURS EARLIER THAN ANTICIPATED. CLINICALLY, THERE IS NO PT HARM. HOWEVER, CASSETTE MANUFACTURER HAS STATED IN ACCOMPANYING LITERATURE THAT A 6% ERROR RATE IN INFUSION TIME IS ALLOWED; HOWEVER, 9 HOURS IS BEYOND THE EXPECTED TIMEFRAME. INFUSION PUMP: CADD LEGACY PLUS MANUFACTURED BY SMITHS MEDICAL MD, INC (B)(4), LOT# 323529 THIS PUMP IS SUPPLIED TO US BY (B)(4), MI CASSETTE: 100ML CAPACITY; LOT# 11X169 EXP: 04/2016 MANUFACTURED BY SMITHS MEDICAL ASD, INC. TREATMENT DATES: (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CADD LEGACY PLUS | CADD AMBULATORY INFUSION PUMP | FRN | SMITHS MEDICAL MD, INC. | 323529 | ||
| 2 | 100 ML CASSETTE | CASSETTE | FPA | SMITHS MEDICAL MD, INC. | 11X169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |