THE LDL-APHERESIS WITH THE LIPOSORBER LA-15 SYSTEM (LDL-A) APPLIED TO THE (B)(6) FEMALE PATIENT (PT) FOR THE TREATMENT OF HER ARTERIO SCLEROSIS OBLITERANS (ASO). IT WAS HER 6TH LDL-A IN THE 2ND SESSION (ONE SESSION USUALLY CONSISTS OF 10 TIMES OF LDL-A). THE PT WAS ON CHRONIC HEMODIALYSIS (HD), 3 TIMES PER WEEK, ON MONDAY, WEDNESDAY AND FRIDAY, AND THIS LDL-A WAS CONDUCTED ON SATURDAY IN THE LATE AFTERNOON. THE LDL-A WAS COMPLETED WITHOUT COMPLICATION EXCEPT FOR A SLIGHT TACHYCARDIA OF OVER 100/MIN. (USUALLY IN AROUND 70/MIN. DURING LDL-A) AND SHE WENT HOME AS USUAL. IN THE LATE AFTERNOON OF THE NEXT DAY, SHE SUFFERED FROM SEVERE DYSPNEA AND WAS TRANSFERRED BY AN AMBULANCE TO A GENERAL HOSPITAL, THAT IS DIFFERENT FROM THE SITE WHERE HER LDL-A HAS BEEN CONDUCTED. THE FAMILY MEMBER OF THE PT MADE A PHONE CALL TO THE PHYSICIAN IN CHARGE FOR HER LDL-A AND INFORMED OF HER PASSING AWAY. NO FURTHER INFORMATION IS AVAILABLE FROM THE PATIENT'S FAMILY.
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Patient 1
NO INFORMATION ABOUT THE CAUSE OF THE PATIENT'S DEATH WAS AVAILABLE TO THE PHYSICIAN IN CHARGE FOR THE PATIENT'S LDL-A, AND ACCORDING TO US, AND IF THE LDL-A WAS RELEVANT TO THE PATIENT'S DEATH COULD NOT BE JUDGED. THE LDL-A ON THE DAY BEFORE THE PATIENT'S DEATH WAS COMPLETED WITHOUT COMPLICATIONS, AND ACCORDINGLY, WE BELIEVE THAT NO DEFECT OR MALFUNCTION OF THE DEVICES USED OCCURRED DURING THE LDL-A. IT IS WELL KNOWN THAT PATIENTS WITH ARTERIOSCLEROSIS OBLITERANCE (ASO), OR PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (PAOD), HAVE COMPLICATIONS SUCH AS CORONARY AND/OR CEREBRAL ARTERY DISEASES, AND ALSO THAT CHRONIC HEMODIALYSIS (HD) PATIENTS HAVE HIGHER RISK FOR HEART FAILURE, CEREBRAL VASCULAR DISEASES AND MYOCARDIAL INFARCTION. THE DEVICE HISTORY RECORD (DHR) OF THE LA-15 WITH LOT NO. LAP1340 (SPECULATED FROM THE DEVICE RECORD AT THE LOCAL DISTRIBUTOR) WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN ITS MANUFACTURING PROCESSES. THE DEVICE MET ITS MATERIAL, ASSEMBLING AND PRODUCT SPECIFICATIONS. ACCORDINGLY, WE BELIEVE THAT THE LDL-A WAS NOT RELEVANT TO THE PATIENT'S DEATH AND A SUDDEN AGGRAVATION OF THE UNDERLING DISEASE(S) AND OR COMPLICATION(S) MAY BE RESPONSIBLE TO THE PATIENT'S DEATH.