FDA Adverse Event
Malfunction
Summary report: N
TUMESCENT INFILTRATION PUMP
MDR report key: 3192527
·
Received June 19, 2013
Report
- Report Number
- 2953189-2013-00049
- Event Type
- Malfunction
- Date Received
- June 19, 2013
- Date of Event
- June 13, 2013
- Report Date
- June 13, 2013
- Manufacturer
- COVIDIEN
- Product Code
- FRN
- PMA / PMN Number
- K071588
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 06/18/2013. 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)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH TUMESCENT INFILTRATION PUMP. THE CUSTOMER STATES THAT WHILE THE PHYSICIAN WAS STEPPING ON THE FOOT PEDAL, THE TUMESCENT PUMP STOPPED PUMPING FLUID. UPON INSPECTION, THE PLASTIC SHAFT BEHIND THE ROLLERS CRACKED IN HALF. THE CUSTOMER STATES THAT THE PHYSICIAN CONTINUED TO INFILTRATE TUMESCENT BY HAND INJECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278967 | TUMESCENT INFILTRATION PUMP | TUMESCENT INFILTRATION PUMP | FRN | COVIDIEN | TPMP-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |