FDA Adverse Event
Malfunction
Summary report: N
CADD CASSETTE 100ML W/FLOWSTOP
MDR report key: 13735562
·
Received March 10, 2022
Report
- Report Number
- MW5108055
- Event Type
- Malfunction
- Date Received
- March 10, 2022
- Date of Event
- January 18, 2022
- Report Date
- January 18, 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
OUTBOUND. PATIENT REPORTED IN THE PAST WEEK TWO CASSETTES CAUSED BOTH PUMPS TO ALARM NO DISPOSABLE AND HAD TO BE DISCARDED AFTER THE INFUSIONS HAD STARTED. STATED ONE TIME, THE ALARM WAS AT NIGHT AND PATIENT STATED SHE DID NOT HEAR THE PUMP AND DID NOT KNOW HOW IT HAD ALARMED. STATED SHE DID FEEL BAD BUT DID NOT SEEK ADDITIONAL CARE. LOT NUMBER 4173642. CASSETTES NOT AVAILABLE FOR RETURN AS PT DISPOSED OF THEM. NO FURTHER DETAILS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2293851 | CADD CASSETTE 100ML W/FLOWSTOP | SET, I.V. FLUID TRANSFER | LHI | SMITHS MEDICAL ASD, INC | 4173642 | ||
| 2293852 | CADD CASSETTE 100ML W/FLOWSTOP | SET, I.V. FLUID TRANSFER | LHI | SMITHS MEDICAL ASD, INC | 4173642 |