FDA Adverse Event
Malfunction
Summary report: N
CADD LEGACY
MDR report key: 7901819
·
Received September 21, 2018
Report
- Report Number
- MW5080056
- Event Type
- Malfunction
- Date Received
- September 21, 2018
- Date of Event
- September 8, 2018
- Report Date
- September 8, 2018
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT INFORMED PHARMACY THAT BOTH OF HIS PUMPS (B)(4) WERE STATING HIGH PRESSURE ALARM BUT INFUSING OK. HE WAS NONSYMPTOMATIC CONFIRMED DRUG WAS INFUSING. PHARMACY SENT REPLACEMENT PUMP JUST IN CASE. NO OTHER INFO IS KNOWN. PT RETURNING MALFUNCTIONING DEVICE. SPONTANEOUS CALL. DOSE OR AMOUNT: 40NKM, FREQUENCY: CONTINUOUS, ROUTE: IV. DATES OF USE: (B)(6) 2016 TO NA. DIAGNOSIS OR REASON FOR USE: I27.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738431 | CADD LEGACY | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. | |||
| 738432 | CADD LEGACY | PUMP, INFUSION | FRN | SMITHS MEDICAL ASD, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |