SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT

Description of Event or Problem

THE CHARGE NURSE AT THE USER FACILITY REPORTED A PATIENT ADVERSE EVENT THAT OCCURRED SOON AFTER THE HEMODIALYSIS (HD) TREATMENT WAS INITIATED. FURTHER EVENT CLARIFICATION REVEALED THAT APPROXIMATELY 10 MINUTES AFTER INITIATION OF THE HD THERAPY THE PATIENT GASPED, AND THEN CODED. THE TREATMENT WAS CANCELLED, AND THE PATIENT WAS REMOVED FROM THE MACHINE. THE CODE CONTINUED FOR ONE HOUR AND THIRTY MINUTES, AFTER WHICH TIME, THE PATIENT EXPIRED. FOLLOW-UP INFORMATION WAS RECEIVED WHICH REVEALED THAT THE EVENT WAS BELIEVED TO HAVE BEEN CAUSED BY A PULMONARY EMBOLISM (PE). ALTHOUGH REQUESTED, NO FURTHER PATIENT SPECIFIC OR EVENT RELATED DETAILS HAVE BEEN MADE AVAILABLE. THE BICARB CONCENTRATE USED FOR THE HD TREATMENT WAS A NON-FRESENIUS MANUFACTURED PRODUCT. BICARBONATE: MEDIVATORS, LIQUID SODIUM BICARB 45X-4 BO CENTRISOL, LOT#: UNKNOWN NI. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).