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 REGISTERED NURSE (RN) STATED BLOOD WAS LEAKING THROUGH WHAT SEEMED LIKE A HOLE IN THE ACTUAL LINE FROM THE BLOOD PUMP TO THE VENOUS LINE. TREATMENT WAS DISCONTINUED AND TREATMENT WAS RE-STRUNG WITH NEW LINES. 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 REGISTERED NURSE (RN) STATED BLOOD WAS LEAKING THROUGH WHAT SEEMED LIKE A HOLE IN THE ACTUAL LINE FROM THE BLOOD PUMP TO THE VENOUS LINE. TREATMENT WAS DISCONTINUED AND TREATMENT WAS RE-STRUNG WITH NEW LINES. 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.