CLIC BLOOD CHAMBER

Description of Event or Problem

A USER FACILITY REPORTED THAT A CRIT-LINE BLOOD CHAMBER LEAKED A FEW DROPLETS OF BLOOD DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. DRIED BLOOD WAS NOTED ON TOP OF THE DIALYZER CAP AT THE END OF A PATIENT¿S FOUR AND A HALF HOUR TREATMENT. THE DRIED BLOOD WAS TRACED TO A SECTION OF THE CRIT-LINE BLOOD CHAMBER WHERE A CRACK WAS IDENTIFIED. THERE WERE NO MACHINE ALARMS THAT OCCURRED. THE PATIENT WAS DIALYZING ON A GAMBRO PHOENIX MACHINE AND UTILIZING A BAXTER REVACLEAR MAX DIALYZER. THERE WAS NO LEAKAGE DURING THE PRIMING; EVERYTHING HAD SEEMED NORMAL. BLOOD LOSS WAS REPORTEDLY VERY SCANT, AND A PHOTO OF THE BLOOD DROPLETS ON THE DIALYZER WAS PROVIDED FOR REVIEW. ESTIMATED BLOOD LOSS (EBL) WAS REPORTED TO BE 0.5 ML. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. IT WAS CONFIRMED THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT. THE SAMPLE WAS REPORTEDLY AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

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: THE COMPLAINT SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE SAMPLE WAS NOT RETURNED IN ITS ORIGINAL PACKAGING. A VISUAL INSPECTION WAS PERFORMED ON THE CLIC BLOOD CHAMBER, AND THE DEVICE WAS FOUND TO BE ACCEPTABLE WITH NO DAMAGE OBSERVED. THE SAMPLE WAS TESTED ON A MACHINE, AND IT WORKED AS INTENDED WITHOUT ANY ABNORMALITIES. 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. 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. UPON COMPLETION OF THE EVALUATION, THERE WERE NO MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ALLEGED FAILURE COULD NOT BE CONFIRMED.

Description of Event or Problem

A USER FACILITY REPORTED THAT A CRIT-LINE BLOOD CHAMBER LEAKED A FEW DROPLETS OF BLOOD DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. DRIED BLOOD WAS NOTED ON TOP OF THE DIALYZER CAP AT THE END OF A PATIENT¿S FOUR-AND-A-HALF-HOUR TREATMENT. THE DRIED BLOOD WAS TRACED TO A SECTION OF THE CRIT-LINE BLOOD CHAMBER WHERE A CRACK WAS IDENTIFIED. THERE WERE NO MACHINE ALARMS THAT OCCURRED. THE PATIENT WAS DIALYZING ON A GAMBRO PHOENIX MACHINE AND UTILIZING A BAXTER REVACLEAR MAX DIALYZER. THERE WAS NO LEAKAGE DURING THE PRIMING; EVERYTHING HAD SEEMED NORMAL. BLOOD LOSS WAS REPORTEDLY VERY SCANT, AND A PHOTO OF THE BLOOD DROPLETS ON THE DIALYZER WAS PROVIDED FOR REVIEW. ESTIMATED BLOOD LOSS (EBL) WAS REPORTED TO BE 0.5 ML. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. IT WAS CONFIRMED THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT. THE SAMPLE WAS REPORTEDLY AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.