Description of Event or Problem · 0
EXPERIENCED A SERIOUS RECURRING PROBLEM DURING PLASMA DONATIONS AT (B)(6). I HAVE COMPLETED MORE THAN 30 DONATIONS AT THIS CATION AND MORE THAN 40 ADDITIONAL DONATIONS AT BIOLIFE (31) AND CSL (13). AT BIOLIFE AND CSL, (B)(6) NEVER EXPERIENCED RETURN-CYCLE ISSUES, HIGH RETURN-PRESSURE ALARMS, FILTER OBSTRUCTION, OR ANY ADVERSE EVENT. THE ONLY EXCEPTION WAS A SINGLE OCCURRENCE AT BIOLIFE IN WHICH A TECHNICIAN COULD NOT PROPERLY ACCESS MY VEIN, PREVENTING THE RETURN OF MY BLOOD. THIS WAS A HUMAN TECHNICAL ERROR, NOT RELATED TO PRESSURE OR EQUIPMENT, AND IT NEVER HAPPENED AGAIN. AT (B)(6), HOWEVER, EVERY DONATION FOLLOWS THE SAME MECHANICAL FAILURE PATTERN: DURING THE FINAL RETURN CYCLE, THE APHERESIS MACHINE TRIGGERS A HIGH UM PRESSURE ALARM AND CANNOT RETURN MY BLOOD UNLESS STAFF MANUALLY INTERVENE. MY DONATION SESSIONS ROUTINELY LAST 2.5 TO 3 HOURS INSTEAD OF THE NORMAL 45-70 MINUTES OTHER CENTERS. TECHNICIANS REPEATEDLY USE IMPROVISED AND UNSAFE METHODS TO FORCE THE RETURN CYCLE TO CONTINUE. THESE INCLUDE STRIKING THE FILTER HOUSING WITH A PEN AND ATTACHING A EKING CLAMP TO THE SENSOR LINE SO THE MACHINE STOPS DETECTING THE HIGH-PRESSURE CONDITION. CLAMPING THE SENSOR LINE DISABLES THE SAFETY SYSTEM AND FORCES THE MACHINE PUSH BLOOD BACK DESPITE ABNORMAL RESISTANCE, WHICH APPEARS TO VIOLATE PROPER DEVICE-OPERATION PROCEDURES AND MAY CAUSE HEMOLYSIS OR PRESSURE-RELATED INJURY. ALSO OBSERVED THESE SAME IMPROVISED INTERVENTIONS BEING PERFORMED ON MULTIPLE OTHER DONORS ON DIFFERENT DAYS. I WITNESSED TECHNICIANS STRIKING THE FILTER WITH A PEN AND CLAMPING THE SENSOR LINE ON SEVERAL DONORS, NOT ONLY ON ME. THIS SHOWS THAT THESE UNSAFE PRACTICES ARE ROUTINE AND NOT AN ISOLATED EVENT. STAFF REPEATEDLY BLAMED RATION AS THE CAUSE, BUT THIS EXPLANATION DOES NOT MAKE SENSE WHEN THE SAME PROBLEM OCCURS WITH MULTIPLE DONORS AND ONLY AT THIS LOCATION. IF ALL DONORS WERE TRULY DEHYDRATED, THE FACILITY SHOULD NOT HAVE ALLOWED ANY OF US TO DONATE. THE REPEATED HIGH-PRESSURE ALARMS ACROSS DIFFERENT DONORS STRONGLY SUGGEST A SYSTEMIC EQUIPMENT OPERATIONAL ISSUE. I ALSO WANT TO NOTE THAT (B)(6) HAVE 22 YEARS OF PROFESSIONAL EXPERIENCE WORKING WITH HOSPITAL MEDICAL EQUIPMENT IN BRAZIL, INCLUDING ANESTHESIA MACHINES, I SYSTEMS, PATIENT MONITORS, AND OTHER CLINICAL DEVICES. THIS BACKGROUND ALLOWED ME TO IMMEDIATELY RECOGNIZE THAT THE INTERVENTIONS PERFORMED BY STAFF WERE IMPROVISATIONS RATHER THAN PROPER PROCEDURES. THE FACILITY IS UNDER CONSTRUCTION INSIDE THE DONOR AREA. DURING THE MOST RECENT INCIDENT, AFTER MULTIPLE HIGH-RETURN-PRESSURE ALARMS, TECHNICIANS CALLED THE UNIT DIRECTOR "RICH." HE APPROACHED VISIBLY IRRITATED AND IMMEDIATELY BLAMED ME WITHOUT ASKING ANY QUESTIONS. HE SAID, "YOU CAN'T TOUCH THIS MACHINE. YOU ARE NO LONGER ALLOWED TO DONATE HERE, WHICH MADE ME FEEL COMPLETELY DISMISSED AS A HUMAN BEING. I HAD ALREADY BEEN CONNECTED TO THE MACHINE FAR LONGER THAN ANY OTHER DONOR; SEVERAL DONORS WHO ARRIVED AFTER ME COMPLETED THEIR ENTIRE DONATION CYCLES AND LEFT WHILE I REMAINED THROUGH REPEATED HIGH-RETURN-PRESSURE ALARMS WITHOUT EFFECTIVE ASSISTANCE. A TECHNICIAN CAME TO ME AT LEAST THREE TIMES AND COULD NOT RESOLVE THE ISSUE. BECAUSE I URGENTLY NEEDED TO LEAVE THE CHAIR AND USE THE RESTROOM. I BRIEFLY HELD THE SENSOR LINE MYSELF BASED ON MY 22 YEARS OF EXPERIENCE WITH HOSPITAL MEDICAL EQUIPMENT. A TECHNICIAN THEN SHOUTED FROM ACROSS THE ROOM, "HEY, DON'T TOUCH THAT MACHINE!" THIS HAPPENED NOT BECAUSE I CAUSED ANY PROBLEM, BUT BECAUSE I HAD BEEN EFT UNATTENDED FOR TOO LONG. I RECORDED A VIDEO OF THE FINAL MINUTES AND EXPERIENCED NO ARM PAIN OR VENOUS DISCOMFORT, CONFIRMING THE ISSUE IS MECHANICAL, NOT PHYSIOLOGICAL. MY SUCCESSFUL HISTORY AT BIOLIFE AND CSL SUPPORTS THIS CONCLUSION. DEVICE NOT LABELED WITH VISIBLE UDI FOR DONORS. MACHINE IDENTIFICATION NOT ACCESSIBLE TO THE PUBLIC.