Description of Event or Problem · 0
ON 22-JAN-2024, THE COMPANY RECEIVED MW5149727 FROM THE FDA. ACCORDING TO MEDWATCH REPORT MW5149727, THE DESCRIPTION OF THE EVENT IS AS FOLLOWS: "PATIENT WAS BEING TRANSFERRED BETWEEN HOSPITALS WITHIN A HEALTH SYSTEM FOR MORE ADVANCED CARE. PATIENT HAD AN EXISTING TREPROSTINIL (REMUNITY) SUBCUTANEOUS PUMP. UPON RETROSPECTIVE REVIEW OF CHART, THERE WAS NO DOCUMENTATION THAT PUMP WAS EXAMINED BY ADMITTING TEAM. ISSUES AROSE WHEN PATIENT BECAME DISTRESSED AND COULDN'T BREATHE AND NOTED THAT PUMP WAS NOT FUNCTIONING PROPERLY. NOT LONG AFTER PUMP BEGAN MALFUNCTIONING, PATIENT BECAME UNRESPONSIVE AND CODE/RAPID RESPONSE WAS CALLED. PREVIOUS COMMUNICATIONS BETWEEN THE HOSPITALS' PHARMACY DEPARTMENTS WERE ALREADY UNDERWAY AND PHARMACY WAS PROACTIVELY WORKING ON COMPOUNDING INTRAVENOUS INFUSION IN ANTICIPATION OF PATIENT ARRIVAL, HOWEVER, TIMELINE TO NEEDING MEDICATION WAS ACCELERATED DUE TO PREVIOUSLY MENTIONED ISSUES. PHARMACY DELIVERED INTRAVENOUS TREPROSTINIL (REMODULIN) APPROXIMATELY HOURS AFTER THE ORDER WAS PLACED BY PULMONARY ARTERIAL HYPERTENSION (PAH) DOCTOR. ALSO OF NOTE, EVENT REPORT FOCUSED ON ASPECT OF PHARMACY ARRIVING LATE TO CODE/RAPID RESPONSE. THIS REPORTING FAILED TO ACKNOWLEDGE MANY OF THE OTHER FACTORS THAT LED TO RAPID RESPONSE IN THE FIRST PLACE OR MENTION THAT DEVICE ACQUISITION WAS ALSO A KEY ISSUE DURING THIS EVENT." MILLYARD ADVANCED MEDICAL PRODUCTS, LLC HAS INVESTIGATED THIS REPORTED EVENT AND A MATCH WAS NOT CONFIRMED TO EXIST IN THE COMPANY'S DATABASE. A COMPLAINT HAS SUBSEQUENTLY BEEN CREATED FOR THIS REPORTED EVENT, SOLELY BASED ON THE INFORMATION PROVIDED ON THE MEDWATCH FORM. NO COMPONENTS ASSOCIATED WITH THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER FOR FURTHER EVALUATION. DUE TO THE ANONYMOUS NATURE OF THE MEDWATCH REPORT, NO FURTHER INVESTIGATION IS POSSIBLE.