FDA Adverse Event
Malfunction
Summary report: N
TUMESCENT INFILTRATION PUMP
MDR report key: 3221795
·
Received July 2, 2013
Report
- Report Number
- 2953189-2013-00052
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 11, 2013
- Manufacturer
- COVIDIEN
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 07/01/2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH TUMESCENT INFILTRATION PUMP. THE CUSTOMER STATES THAT PLASTIC SHAFT ON ROLLER OF THE TUMESCENT PUMP WAS SNAPPED DURING PROCEDURE. CUSTOMER STATES THAT THE TUMESCENT MOTOR RUNS BUT WILL NOT FEED ANY FLUID DUE TO THE BROKEN SHAFT. NO MEDICAL INTERVENTION. NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300964 | TUMESCENT INFILTRATION PUMP | TUMESCENT INFILTRATION PUMP | FRN | COVIDIEN | TPMP-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |