FDA Adverse Event
Malfunction
Summary report: N
B/F WARM SET W/48" EXT CE
MDR report key: 3825332
·
Received May 21, 2014
Report
- Report Number
- 0001831750-2014-03007
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Date of Event
- April 28, 2014
- Report Date
- April 28, 2014
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- KZL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CASSETTE WAS RETURNED AND THE CONDITION WAS CONFIRMED BY A STRYKER REPRESENTATIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE USER FACILITY NOTICED SHAVINGS AROUND THE FEMALE PORT OF THE BLOOD FLUID WARMER CASSETTE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE USER FACILITY NOTICED SHAVINGS AROUND THE FEMALE PORT OF THE BLOOD FLUID WARMER CASSETTE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302311 | B/F WARM SET W/48" EXT CE | DEVICE, WARMING. BLOOD AND PLASMA | KZL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |