FDA Adverse Event
Malfunction
Summary report: N
CADD CASSETTE 100ML W/FLOWSTOP
MDR report key: 13736260
·
Received March 10, 2022
Report
- Report Number
- MW5108069
- Event Type
- Malfunction
- Date Received
- March 10, 2022
- Date of Event
- January 6, 2022
- Report Date
- January 6, 2022
- Manufacturer
- SMITHS MEDICAL ASD, INC
- Product Code
- LHI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
INBOUND.NO DISPOSABLE PUMP ALARM USING 100ML CASSETTE FROM LOT 4173645 EXPIRATION 08/19/2026, REPLACEMENT PUMP SENT, NO FURTHER DETAILS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1872302 | CADD CASSETTE 100ML W/FLOWSTOP | SET, I.V. FLUID TRANSFER | LHI | SMITHS MEDICAL ASD, INC | 4173645 | ||
| 1872303 | PUMP | PUMP, INFUSION | LHI | SMITHS MEDICAL ASD, INC |