MINIBORE EXT SET 60IN NDEHP

Description of Event or Problem

THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY FOLLOWING A CRACK; SUBSEQUENTLY A LEAK WAS NOTED. THE MALE ADAPTER OF A SYRINGE WAS CONNECTED TO THE FEMALE ADAPTER OF THE TUBING SET. THE MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO ONE OF THE TWO FEMALE ADAPTERS OF THE PATIENT'S DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE AND WAS BEING USED TO DELIVER PROSTIN'S 5MCQ/50ML, AT A RATE OF 1.5 ML/HR, VIA A SYRINGE PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF AN UNSPECIFIED TUBING SET WAS CONNECTED AT AN UNSPECIFIED LOCATION ON THE TUBING SET FOR A PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF TOTAL PARENTERAL NUTRITION (TPN). NO ADDITIONAL PUMP PARAMETERS WERE PROVIDED. AT 23:00, THE CUSTOMER CONTACT REPORTED THAT THE PATIENT'S BLOOD PRESSURE (BP) WAS 55/49MMHG AND THAT THE PATIENT'S URINE OUTPUT DECREASED TO AN UNSPECIFIED VOLUME. AT 23:30, IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM A CRACK IN THE FEMALE ADAPTER OF THE TUBING SET WAS NOTED. AT THIS TIME, THE CUSTOMER CONTACT REPORTED THAT BACKFLOW OF TPN SOLUTION INTO THE PROSTIN SYRINGE WAS NOTED. AT AN UNSPECIFIED TIME, THE PATIENT WAS TREATED WITH UNSPECIFIED VOLUME OF A NORMAL SALINE. THE CUSTOMER CONTACT REPORTED THAT THE TUBING SET AND PROSTIN SYRINGE WERE REPLACED AND THE THERAPY WAS RESUMED. IT WAS REPORTED THAT APPROXIMATELY 30 MINUTES AFTER THE THERAPY WAS RESUMED, THE PATIENT'S BP WAS 77/38 MMHG. ON (B)(6) 2014 AT 00:30, IT WAS REPORTED THAT THE PATIENT'S BP WAS 87/40 MMHG. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.