LS LF REG EXT SET NON-DEHP
Received Apr 12, 2013 · Event occurred Mar 1, 2013
Report 9613251-2013-00110 · MDR key 3069373
Device
Product problems
- Failure to Deliver
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF NO FLOW. ON UNSPECIFIED DATES, THE MALE ADAPTER OF UNSPECIFIED PRIMARY TUBING SETS WERE CONNECTED TO THE FEMALE ADAPTER OF THE EXTENSION TUBING SETS AND WERE BEING USED TO DELIVER UNSPECIFIED ANTIBIOTICS, AT UNSPECIFIED RATES. AFTER UNSPECIFIED LENGTHS OF TIME, AFTER THE DELIVERIES WERE STARTED, NO FLOW OF SOLUTIONS WERE NOTED. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED INCLUDING IF THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED.
Additional Manufacturer Narrative
THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED NO FLOW WERE IDENTIFIED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.