Description of Event or Problem · 1
A (B)(6) F (B)(6)2012. SHE PRESENTED FOR ADMISSION WITH ACUTE ON CHRONIC CHF, DIASTOLIC MODERATE-SEVERE WITH EF 65% FOR SOME WEEKS OF LETHARGY, MALAISE, LARGE EDEMA/ANASARCA DEVELOPMENT REPORTEDLY 25 ABOVE TRANSAMINITIS WITH SUSPICION OF CARDIAC LIVER CONGESTION. PT AND HER SON RELATE CONSIDERING CONSERVATIVE APPROACH AND ACCEPTING FURTHER DECLINE EVEN IF TERMINAL, BUT DID FINALLY AGREE TO COME FOR PALLIATIVE AQUAPHARESIS. A 9 LITER ULTRAFILTERED IN THE FIST 48 HRS FOR NET NEGATIVE 6500 -ALBEIT THERE WAS NO RECORDED URINE OUTPUT DURING THIS TIME. AQUAPHARESIS WAS STOPPED (B)(6). PT TRANSFERRED TO ICU FOR LETHARGY AND SEVERE HYPOGLYCEMIA. THROMBOCYTOPENIA, MILD ANEMIA AND CONCERNS OF HEMOLYSIS WERE IDENTIFIED AND SEEMINGLY CONFIRMED WITH LDH 2600 AND UNDETECTABLE HAPTOGLOBIN. RENAL AND HEME WERE ACUTELY CONSULTED. INTERESTINGLY, SCHISTOCYTES WERE NOT IDENTIFIED. INR WAS ELEVATED AT 4 BUT PT HAD HER COUMADIN HELD PRIOR TO ADMIT AND THE INR WAS 1.7 ON ADMIT. ISSUE OF ACUTE HEMOLYTIC ANEMIA BEING INVESTIGATED. DIFFERENTIAL IS BROAD AT THIS POINT, BUT OF CONSIDERATION IS THE POSSIBILITY OF AQUAPHARESIS "MECHICIAL" PRESSURE TRAUMA, MEMBRANE REACTION, OR MEMBRANE CHEMICAL REACTION. PT/FAMILY NOTIFIED OF THE POSSIBILITY. NURSING SUPERVISOR AND PATIENT SAFETY NOTIFIED AND DISCUSSED. FILTER ITSELF LOCATED AND SAVED IF DEEMED APPROPRIATE FURTHER INVESTIGATION. AQUAPHARESIS MACHINE IDENTIFIED AND THOROUGH BIO-MED EVALUATION ACUTELY REQUESTED. RECOMMENDATIONS FOR HOLDING ALL FURTHER AQUAPHARESIS UNTIL APPROPRIATE SAFETY CHECKS COULD BE DONE INCLUDING NOTIFY / COUNSEL FROM FILTER COMPANY AND FDA CAN BE COMPLETED ON PREMISE OF POSSIBLE PRODUCTION ISSUE BY WHICH OTHER FILTERS COULD BE CONSIDERED AT RISK. CERTAINLY NOT ANYTHING DEFINITIVE, BUT ACTING OUT OF SAFETY UNTIL FURTHER DEFINED SYNDROME. ULTRAFILTRATION (B)(6) 2012.