LS LF REG EXT SET NON-DEHP
Received Apr 16, 2014 · Event occurred Mar 18, 2014
Report 9613251-2014-00082 · MDR key 3821124
Device
Product problems
- Material Separation
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
GENERAL REPORT REC'D OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF SEPARATIONS. ON UNSPECIFIED DATES, THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED CONCENTRATIONS OF VANCOMYCIN VIA GRAVITY. AFTER UNSPECIFIED LENGTHS OF TIMES AFTER THE DELIVERIES WERE STARTED, THE TUBING SEPARATED FROM THE OUTLET PORT ON THE DIAL-A-FLOW OF THE TUBING SETS AND UNSPECIFIED VOLUMES OF SOLUTION LEAKED. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Additional Manufacturer Narrative
ONE SEALED DEVICE WAS REC'D AND EVALUATED. THE DEVICE PASSED TESTING. NO TUBING SEPARATIONS WERE NOTED. ALTHOUGH THE DEVICE PASSED TESTING, DURING THE INVESTIGATION, A PROBABLE CAUSE FOR THE CUSTOMER REPORTED SEPARATION WAS IDENTIFIED. THE PROBABLE CAUSE OF THE SEPARATION COULD HAVE BEEN DUE TO INSUFFICIENT SOLVENT APPLICATION DURING MFG. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.