FDA Adverse Event
Malfunction
Summary report: N
LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS
MDR report key: 2123555
·
Received June 9, 2011
Report
- Report Number
- 2183502-2011-00473
- Event Type
- Malfunction
- Date Received
- June 9, 2011
- Date of Event
- May 11, 2011
- Report Date
- June 7, 2011
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- KZL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE, AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT THE PRODUCT WAS PRIMED WITH INFUSION SOLUTION WHEN LEAKAGE WAS NOTED AT THE BOTTOM OF THE HEAT EXCHANGER. ACCORDING TO REPORTER, THE SOLUTION LEAKED ONTO CLINICIAN AS A RESULT. NO ADVERSE EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS | KZL -- DISPOSABLE IV FLUID WARMING SET | KZL | SMITHS MEDICAL ASD, INC. | NA | 1961904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |