FDA Adverse Event
Malfunction
Summary report: N
LEGACY PLUS
MDR report key: 11628861
·
Received April 6, 2021
Report
- Report Number
- MW5100603
- Event Type
- Malfunction
- Date Received
- April 6, 2021
- Date of Event
- March 29, 2021
- Report Date
- April 2, 2021
- Manufacturer
- SMITHS MEDICAL ASD, INC
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
FOUR PATIENTS HAD CADD PUMP DISPENSED FOR 46 HR INFUSION, AT SOME POINT IN THE NEXT 24 HRS ALL GAVE "NO DISPOSABLE FOUND" ALARM. PATIENTS RETURNED THE NEXT MORNING TO CLINIC AND MEDICATIONS WAS DISPENSED USING A EMPTY BAG AND A DIFFERENT SET OF TUBING. NO CASSETTE INVOLVED. NO HARM TO ANY PATIENTS, AND NO SIGNIFICANT INTERRUPTION TO THERAPY. THREE OF THE PATIENTS HAD THE SAME CASSETTE LOTS #4092491, EXP 1-18-2026 AND ONE HAD 4084027, EXP 12/2/2025. NEW PUMPS ISSUED. NO PROBLEMS NOTED AND INFUSION COMPLETED. THREE OF THE ASSOCIATED PATIENTS HAD USED THE SAME PUMP WITHOUT INCIDENT. ONE PATIENT HAD ISSUES WITH TWO PUMPS DISPLAYING THE SAME ERROR MESSAGE WITH DIFFERENT PUMPS. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522987 | LEGACY PLUS | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC | 21-7302-24 | ||
| 522988 | LEGACY PLUS | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC | |||
| 522989 | LEGACY PLUS | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC | |||
| 522990 | LEGACY PLUS | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |