FDA Adverse Event
Malfunction
Summary report: N
CASSETTE MEDI RESERVOIR
MDR report key: 12985095
·
Received December 10, 2021
Report
- Report Number
- MW5105969
- Event Type
- Malfunction
- Date Received
- December 10, 2021
- Report Date
- December 8, 2021
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- LHI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- *
Narratives
Description of Event or Problem · 0
SPONTANEOUS CALL; PT STATES THAT 2 CASSETTES LOT# 4163625 [BOTH) CAUSED MIXING ISSUES, NOT ALLOWING HER TO INFUSE AND LOST 2 DAYS WORTH OF MEDICATION. NO OTHER INFORMATION KNOWN. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? NO; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION? NO; DID WE [MFR] REPLACE THE CASSETTE? YES; DID THE PT HAVE ADD'L CASSETTES THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1871792 | CASSETTE MEDI RESERVOIR | SET, I.V, FLUID TRANSFER | LHI | SMITHS MEDICAL ASD, INC. | 4163625 | ||
| 1871793 | CASSETTE MEDI RESERVOIR | SET, I.V, FLUID TRANSFER | LHI | SMITHS MEDICAL ASD, INC. | 4163625 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |