2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP

Additional Manufacturer Narrative

CORRECTION: G2 PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE COMPLAINT INVESTIGATION DID NOT FIND OBJECTIVE EVIDENCE INDICATING A PRODUCT PROBLEM, AND THUS THE COMPLAINT WAS NOT CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

Description of Event or Problem

A HOME HEMODIALYSIS (HD) PATIENT REPORTED THEY FORGOT TO UNCLAMP THE HEPARIN LINE DURING THEIR TREATMENT ON A FRESENIUS 2008K@HOME MACHINE, AND THE MACHINE FAILED TO ALARM. THE INCIDENT RESULTED IN BLOOD LOSS DUE TO BLOOD WITHIN THE SYSTEM COAGULATING AFTER FOUR HOURS OF TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 180 ML. UPON FOLLOW-UP WITH THE FIELD SERVICE TECHNICIAN (FST) FAMILIAR WITH THE EVENT, IT WAS INDICATED THAT USE ERROR WAS POSSIBLY INVOLVED. WHEN THE TECHNICIAN TESTED THE HEPARIN PUMP, IT WAS CONFIRMED THAT THE MACHINE ALARMED APPROPRIATELY. ALTHOUGH THE PATIENT FORGOT TO UNCLAMP THE HEPARIN LINE, THE TECHNICIAN STATED THAT THE MACHINE SHOULD HAVE PRODUCED A HEPARIN PUMP ALARM. IT WAS CONFIRMED THAT THE PATIENT WAS USING THE HEPARIN PUMP FOR THE TREATMENT. THE TECHNICIAN STATED THERE WAS NO BOLUS DELIVERY SET UP, BUT THE HEPARIN PUMP SETTINGS WERE REPORTEDLY SET PROPERLY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

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 HOME HEMODIALYSIS (HD) PATIENT REPORTED THEY FORGOT TO UNCLAMP THE HEPARIN LINE DURING THEIR TREATMENT ON A FRESENIUS 2008K@HOME MACHINE, AND THE MACHINE FAILED TO ALARM. THE INCIDENT RESULTED IN BLOOD LOSS DUE TO BLOOD WITHIN THE SYSTEM COAGULATING AFTER FOUR HOURS OF TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 180 ML. UPON FOLLOW-UP WITH THE FIELD SERVICE TECHNICIAN (FST) FAMILIAR WITH THE EVENT, IT WAS INDICATED THAT USE ERROR WAS POSSIBLY INVOLVED. WHEN THE TECHNICIAN TESTED THE HEPARIN PUMP, IT WAS CONFIRMED THAT THE MACHINE ALARMED APPROPRIATELY. ALTHOUGH THE PATIENT FORGOT TO UNCLAMP THE HEPARIN LINE, THE TECHNICIAN STATED THAT THE MACHINE SHOULD HAVE PRODUCED A HEPARIN PUMP ALARM. IT WAS CONFIRMED THAT THE PATIENT WAS USING THE HEPARIN PUMP FOR THE TREATMENT. THE TECHNICIAN STATED THERE WAS NO BOLUS DELIVERY SET UP, BUT THE HEPARIN PUMP SETTINGS WERE REPORTEDLY SET PROPERLY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.