COMBISET BLOODLINE

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) STATED THE DIALYSIS LINE BECAME SEPARATED DURING THE LAST 10 MINUTES OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE DIALYSIS LINE SEPARATED RIGHT AFTER THE BLOOD PUMP SEGMENT BY THE HEPARIN PUMP. UPON FOLLOW-UP, THE CM STATED A HEMODIALYSIS (HD) PATIENT HAD 10 MINUTES LEFT OF DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN STAFF NOTICED BLOOD LEAKING FROM THE DIALYSIS LINE BETWEEN THE BLOOD PUMP SEGMENT AND THE HEPARIN PUMP. THE CM CONFIRMED THE LEAK DID NOT OCCUR ON THE TUBING LINE AT THE BLOOD PUMP SEGMENT BUT WAS UNABLE TO SPECIFY THE EXACT LOCATION OF THE LEAK ON THE TUBING LINE. TREATMENT WAS IMMEDIATELY HALTED AND THE STAFF REPORTED CLAMPING OF THE LINES. A FRESENIUS DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS NOT RETURNED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 300 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE MACHINE WAS REMOVED FROM THE FLOOR DUE TO BLOOD CONTACT WITH THE MACHINE AND REMAINS OUT OF SERVICE. FOLLOWING THE EVENT, THE CM STATED THE PATIENT ENDED TREATMENT AS THE PATIENT HAD LESS THAN 10 MINUTES LEFT OF TREATMENT. THE PATIENT HAS SINCE RESUMED TREATMENT WITHOUT FURTHER ISSUE. THE COMPLAINT DEVICE WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

Additional Manufacturer Narrative

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

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 CLINIC MANAGER (CM) STATED THE DIALYSIS LINE BECAME SEPARATED DURING THE LAST 10 MINUTES OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE DIALYSIS LINE SEPARATED RIGHT AFTER THE BLOOD PUMP SEGMENT BY THE HEPARIN PUMP. UPON FOLLOW-UP, THE CM STATED A HEMODIALYSIS (HD) PATIENT HAD 10 MINUTES LEFT OF DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN STAFF NOTICED BLOOD LEAKING FROM THE DIALYSIS LINE BETWEEN THE BLOOD PUMP SEGMENT AND THE HEPARIN PUMP. THE CM CONFIRMED THE LEAK DID NOT OCCUR ON THE TUBING LINE AT THE BLOOD PUMP SEGMENT BUT WAS UNABLE TO SPECIFY THE EXACT LOCATION OF THE LEAK ON THE TUBING LINE. TREATMENT WAS IMMEDIATELY HALTED AND THE STAFF REPORTED CLAMPING OF THE LINES. A FRESENIUS DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS NOT RETURNED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 300 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE MACHINE WAS REMOVED FROM THE FLOOR DUE TO BLOOD CONTACT WITH THE MACHINE AND REMAINS OUT OF SERVICE. FOLLOWING THE EVENT, THE CM STATED THE PATIENT ENDED TREATMENT AS THE PATIENT HAD LESS THAN 10 MINUTES LEFT OF TREATMENT. THE PATIENT HAS SINCE RESUMED TREATMENT WITHOUT FURTHER ISSUE. THE COMPLAINT DEVICE WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.