NDHP LS MICRBR CLAVE
Received Mar 17, 2014 · Event occurred Feb 17, 2014
Report 9613251-2014-00064 · MDR key 3832617
Device
Product problems
- Device Displays Incorrect Message
- Positioning Problem
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CONTACT REPORTED THAT THE SILICONE SLEEVE OF THE CLAVE PORT ON THE EXTENSION TUBING SET REMAINED IN THE DEPRESSED POSITION. THE CUSTOMER CONTACT REPORTED THAT THE MALE ADAPTER OF A PRIMARY TUBING SET WAS CONNECTED TO THE CLAVE PORT ON THE EXTENSION TUBING SET AND BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT A RATE OF 20 ML/HOUR, VIA A PUMP. THE CUSTOMER CONTACT REPORTED THAT AFTER THE SET UP WAS COMPLETE, THE PUMP ALARMED FOR OCCLUSION. AT THAT TIME, IT WAS REPORTED THAT THE MALE ADAPTER OF THE PRIMARY TUBING SET WAS DISCONNECTED FROM THE CLAVE PORT ON THE EXTENSION TUBING SET AND THE SILICONE SLEEVE OF THE CLAVE PORT ON THE EXTENSION TUBING SET WAS REPLACED AND THERAPY WAS RESUMED. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.