Description of Event or Problem · 0
SPOKE WITH PATIENT'S SPOUSE FOR MONTHLY IV REMODULIN CONSULT. PATIENT IS AT MAINTENANCE. DOSE 55 NKM, 39 ML/24HR PUMP RATE. PATIENT'S SPOUSE SAID THAT THERE HAVE BEEN TWO SEPARATE OCCASIONS WHERE THE PATIENT'S IV INVISION CONNECTORS HAVE DISINTEGRATED AND CAUSED BLOOD TO GET INTO HER CENTRAL LINE. SPOUSE SAYS THAT THE GREEN VALVE PART ON THE BOTTOM IS USUALLY WHERE IT FALLS APART/"DISINTEGRATES" AND HER LINE WILL THEN GET INFILTRATED. SPOUSE SAID THAT BOTH TIMES PATIENT CHANGED THE CONNECTOR AND THE LINE ENDED UP BEING FINE. SPOUSE SAYS THAT THE PATIENT USED A DIFFERENT CONNECTOR WHEN SHE WAS WITH ACCREDO PREVIOUSLY AND LIKED THOSE CONNECTORS BETTER. SPOUSE WAS UNABLE TO PROVIDE ME THE NAME OF THE CONNECTOR. AUTHOR ADVISED THAT WE WILL REACH OUT TO (B)(6) FIELD NURSE [CNSS) TEAM TO SEE IF THEY CAN ASSIST WITH IDENTIFYING THE OTHER CONNECTOR AND SEE IF WE CAN SUPPLY THAT CONNECTOR TO THE PATIENT. PRACTICE "LIELSON" TO REFILL, MD OFFICE OF THE ABOVE AS WELL. SERIAL NUMBER NOT PROVIDED. PT DID NOT MISS A DOSE OR EXPERIENCED ANY ADVERSE EVENTS DUE TO DEFECTIVE PRODUCT. LOT NUMBER AND EXP DATE ARE UNK. PT DOES NOT HAVE DEFECTIVE PRODUCT ON HAND FOR POSSIBLE RETURN. NO FURTHER INFO. REPORTED TO (B)(6) BY PT/CAREGIVER. REF REPORT: MW5145106.