COMBISET BLOODLINE

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) REPORTED THE COMBISET BLOODLINES WERE CLOTTING (NOT DIALYZERS) RESULTING IN A PATIENT SAFETY EVENT AND INABILITY TO RETURN BLOOD, ESPECIALLY 4 HOUR TREATMENTS. FREQUENT AIR DETECTOR ALARMS PROMPTED HALFWAY THROUGH TREATMENT. ARTERIAL DID NOT FLOW BY GRAVITY WHEN SETTING UP PER POLICY AND PROCEDURE. THE ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED THE COMBISET BLOODLINES WERE CLOTTING (NOT DIALYZERS) RESULTING IN A PATIENT SAFETY EVENT AND INABILITY TO RETURN BLOOD, ESPECIALLY 4 HOUR TREATMENTS. FREQUENT AIR DETECTOR ALARMS PROMPTED HALFWAY THROUGH TREATMENT. ARTERIAL DID NOT FLOW BY GRAVITY WHEN SETTING UP PER POLICY AND PROCEDURE. THE ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

Additional Manufacturer Narrative

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