COMBISET ACCESS FLOW REVERSE CON TWISTER

Additional Manufacturer Narrative

PLANT INVESTIGATION: AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE PERFORMED. A BATCH RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER FOR THE REPORTED LOT. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. IN ADDITION, A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE LOT MET ALL SPECIFICATIONS FOR RELEASE. A PRODUCT HISTORY REVIEW DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.

Description of Event or Problem

A USER FACILITY CLINICAL MANAGER (CM) CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT A COMBI SET BLOODLINE CAME APART DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT, WHICH RESULTED IN AN UNSPECIFIED AMOUNT OF PATIENT BLOOD LOSS. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE CM, AS WELL AS A PATIENT CARE TECHNICIAN (PCT) FAMILIAR WITH THE EVENT. REPORTEDLY, THE TWO LINES CONNECTED TO THE WHITE WHEEL ON THE COMBI SET TWISTER LINES SEPARATED (OR ¿BROKE OFF¿) WHEN THE OPERATOR TWISTED IT (AS PROMPTED TO DO SO BY THE MACHINE). THIS OCCURRED APPROXIMATELY THIRTY-FIVE TO FORTY MINUTES INTO THE PATIENT¿S TREATMENT. WHEN THIS HAPPENED, BLOOD SQUIRTED OUT OF THE LINES AND GOT ALL OVER THE OPERATOR OF THE MACHINE. THERE WERE NO ALARMS LEADING UP TO THE EVENT, BUT THE FRESENIUS 2008T MACHINE DID ALARM WITH AN AIR DETECTOR ALARM WHEN THE SEPARATION OCCURRED. ACCORDING TO THE CM, THERE HAD BEEN NO CHANGES OR ADJUSTMENTS MADE TO THE PATIENT¿S BLOOD FLOW RATE IMMEDIATELY PRECEDING THE SEPARATION. THE PATIENT¿S BLOOD WAS NOT RETURNED, AND THEIR ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. IT WAS CONFIRMED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, SERIOUS INJURIES, OR REQUIRE MEDICAL INTERVENTION DUE TO THE EVENTS. THE PATIENT WAS RESTARTED WITH NEW SUPPLIES ON THE SAME MACHINE AND COMPLETED THEIR TREATMENT WITHOUT FURTHER ISSUE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT HAD BEEN DISCARDED. ADDITIONALLY, NO PHOTOS OF THE REPORTED DEFECT WERE AVAILABLE FOR REVIEW.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A USER FACILITY CLINICAL MANAGER (CM) CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT A COMBI SET BLOODLINE CAME APART DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT, WHICH RESULTED IN AN UNSPECIFIED AMOUNT OF PATIENT BLOOD LOSS. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE CM, AS WELL AS A PATIENT CARE TECHNICIAN (PCT) FAMILIAR WITH THE EVENT. REPORTEDLY, THE TWO LINES CONNECTED TO THE WHITE WHEEL ON THE COMBI SET TWISTER LINES SEPARATED (OR ¿BROKE OFF¿) WHEN THE OPERATOR TWISTED IT (AS PROMPTED TO DO SO BY THE MACHINE). THIS OCCURRED APPROXIMATELY THIRTY-FIVE TO FORTY MINUTES INTO THE PATIENT¿S TREATMENT. WHEN THIS HAPPENED, BLOOD SQUIRTED OUT OF THE LINES AND GOT ALL OVER THE OPERATOR OF THE MACHINE. THERE WERE NO ALARMS LEADING UP TO THE EVENT, BUT THE FRESENIUS 2008T MACHINE DID ALARM WITH AN AIR DETECTOR ALARM WHEN THE SEPARATION OCCURRED. ACCORDING TO THE CM, THERE HAD BEEN NO CHANGES OR ADJUSTMENTS MADE TO THE PATIENT¿S BLOOD FLOW RATE IMMEDIATELY PRECEDING THE SEPARATION. THE PATIENT¿S BLOOD WAS NOT RETURNED, AND THEIR ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. IT WAS CONFIRMED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, SERIOUS INJURIES, OR REQUIRE MEDICAL INTERVENTION DUE TO THE EVENTS. THE PATIENT WAS RESTARTED WITH NEW SUPPLIES ON THE SAME MACHINE AND COMPLETED THEIR TREATMENT WITHOUT FURTHER ISSUE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT HAD BEEN DISCARDED. ADDITIONALLY, NO PHOTOS OF THE REPORTED DEFECT WERE AVAILABLE FOR REVIEW.