MalfunctionFII
SYSTEM 1000 SPDS
Received Nov 10, 2006 · Event occurred Oct 1, 2006
Report 1423500-2006-01206 · MDR key 788136
Product problems
- Kinked
Patient
UNKNOWN
- No Patient Involvement
Narrative
Description of Event or Problem
ON OCTOBER 11, 2006, A CUSTOMER (RN) REPORTED TO BAXTER CLINICAL CONSULTANT, A KINK IN THE BLOOD TUBING, DURING SET UP OF THE MACHINE, ACCORDING TO THE NEW DIRECTIVE, NOT TO USE THE UPPER CLIP ON THE MACHINE. IT WAS NOTED A 45 DEGREE ANGLE OF THE TUBING AS IT EXITED THE BLOOD PUMP SECTOR. THE PROBLEM WAS NOTED PRIOR TO USE. THERE WAS NO REPORTED PT / USER INJURY OR MEDICAL INTERVENTION.
Additional Manufacturer Narrative
BAXTER IS MONITORING ISSUES LIKE THIS. AN INVESTIGATION STILL PENDING. IF SIGNIFICANT INFO IS DISCOVERED A FOLLOW UP REPORT WILL BE SUBMITTED.