CLIC BLOOD CHAMBER

Description of Event or Problem

A REGISTERED NURSE (RN) REPORTED TO FRESENIUS THAT A CLIC BLOOD CHAMBER LEAKED WITHIN THE FIRST FIVE MINUTES OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS NOTED THAT BLOOD WAS DRIPPING ONTO THE FLOOR. THE RN SAID THAT ONLY A FEW DROPS OF BLOOD HAD LEAKED OUT. THE LEAK WAS COMING FROM THE CRIT-LINE BLOOD CHAMBER, AT THE GLUED CONNECTION JUST BELOW THE BLOOD CHAMBER BODY. THE RN SAID THERE WERE ALSO HIGH VENOUS PRESSURE ALARMS. UPON FOLLOW-UP WITH THE RN IT WAS REPORTED THAT THIS PATIENT USES SMALL BLOODLINES, AND THEREFORE IT WAS NOT UNUSUAL TO SEE ELEVATED VENOUS PRESSURES IN THE SYSTEM. AIR WAS NOT SUSPECTED TO HAVE ENTERED THE CIRCUIT, AND THERE WERE NO ALARMS TO INDICATE SO. THE BLOOD WAS CLEANED UP, AND THE TREATMENT WAS CONTINUED. HOWEVER, BLOOD CONTINUED TO DRIP OUTSIDE OF THE CHAMBER. WHEN IT WAS NOTED THAT THE LEAKING HAD CONTINUED, THE TREATMENT WAS STOPPED AND THE PATIENT¿S BLOOD WAS RETURNED. THERE WAS NO VISIBLE DAMAGE NOTED AT THE LEAK LOCATION. ADDITIONALLY, THERE WERE NO ISSUES NOTED DURING THE PRIME. ESTIMATED BLOOD LOSS (EBL) DUE TO THE LEAK WAS MINIMAL. THE RN ESTIMATED PATIENT BLOOD LOSS TO BE 2ML. AS A PRECAUTION, THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. THE RN CONFIRMED THERE WAS NO PATIENT SERIOUS INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT ON THE SAME MACHINE AFTER BEING RE-SETUP WITH NEW SUPPLIES. A PHOTO WAS PROVIDED (NOT OF THE ACTUAL DEVICE) TO ILLUSTRATE WHERE THE LEAK WAS COMING FROM. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED.

Additional Manufacturer Narrative

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 REGISTERED NURSE (RN) REPORTED TO FRESENIUS THAT A CLIC BLOOD CHAMBER LEAKED WITHIN THE FIRST FIVE MINUTES OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS NOTED THAT BLOOD WAS DRIPPING ONTO THE FLOOR. THE RN SAID THAT ONLY A FEW DROPS OF BLOOD HAD LEAKED OUT. THE LEAK WAS COMING FROM THE CRIT-LINE BLOOD CHAMBER, AT THE GLUED CONNECTION JUST BELOW THE BLOOD CHAMBER BODY. THE RN SAID THERE WERE ALSO HIGH VENOUS PRESSURE ALARMS. UPON FOLLOW-UP WITH THE RN IT WAS REPORTED THAT THIS PATIENT USES SMALL BLOODLINES, AND THEREFORE IT WAS NOT UNUSUAL TO SEE ELEVATED VENOUS PRESSURES IN THE SYSTEM. AIR WAS NOT SUSPECTED TO HAVE ENTERED THE CIRCUIT, AND THERE WERE NO ALARMS TO INDICATE SO. THE BLOOD WAS CLEANED UP, AND THE TREATMENT WAS CONTINUED. HOWEVER, BLOOD CONTINUED TO DRIP OUTSIDE OF THE CHAMBER. WHEN IT WAS NOTED THAT THE LEAKING HAD CONTINUED, THE TREATMENT WAS STOPPED AND THE PATIENT¿S BLOOD WAS RETURNED. THERE WAS NO VISIBLE DAMAGE NOTED AT THE LEAK LOCATION. ADDITIONALLY, THERE WERE NO ISSUES NOTED DURING THE PRIME. ESTIMATED BLOOD LOSS (EBL) DUE TO THE LEAK WAS MINIMAL. THE RN ESTIMATED PATIENT BLOOD LOSS TO BE 2ML. AS A PRECAUTION, THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. THE RN CONFIRMED THERE WAS NO PATIENT SERIOUS INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT ON THE SAME MACHINE AFTER BEING RE-SETUP WITH NEW SUPPLIES. A PHOTO WAS PROVIDED (NOT OF THE ACTUAL DEVICE) TO ILLUSTRATE WHERE THE LEAK WAS COMING FROM. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED.