MalfunctionFPK
TUBING SETS FOR INFILTRATION PUMP
Received May 22, 2013 · Event occurred May 15, 2013
Report 2953189-2013-00043 · MDR key 3170760
Device
Product problems
- Break
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH TUBING SETS FOR INFILTRATION PUMP. THE CUSTOMER STATES THE TUBING BROKE IN THE ROTOR PART AND THE TUMESCENT JUST DRIPS AND DOES NOT FLOW SMOOTHLY. AS A RESULT, THE PROCEDURE TIME WAS EXTENDED. THERE WAS NO IMPACT TO THE PATIENT.
Additional Manufacturer Narrative
SUBMIT DATE: 05/22/2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.