FDA Adverse Event
Malfunction
Summary report: N
DI-60HL IV ADMINISTRATION SET
MDR report key: 792453
·
Received December 16, 2004
Report
- Report Number
- 1221261-2004-00036
- Event Type
- Malfunction
- Date Received
- December 16, 2004
- Date of Event
- October 26, 2004
- Report Date
- November 22, 2004
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: SMITHS MEDICAL ASD, INC. IS UNABLE TO FULLY EVALUATE THIS REPORT AS NO LOT NUMBER OR SAMPLE WAS PROVIDED BY THE USER FACILITY. THIS EVENT WAS FOUND UPON MAINTENANCE AND NOT IN USE. HISTORY OF THIS TYPE OF REPORTS SHOWS THAT THE ROOT CAUSE WAS LIKELY A HOLE IN THE HEAT EXCHANGER.
Description of Event or Problem · 1
USER ALLEGES THAT DURING CLEANING THE DEVICE, THE TECHNICIAN FOUND SOME BLOOD IN THE WATER OF THE FLUID WARMER DEVICE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DI-60HL IV ADMINISTRATION SET | IV ADMINISTRATION SET | FPA | SMITHS MEDICAL ASD, INC. | DI-60HL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | LEVEL 1 FLUID WARMER |