COMBISET BLOODLINE

Description of Event or Problem

A USER FACILITY CLINIC MANAGER REPORTED BLOOD LEAKING AT THE BLOOD PUMP FROM THE COMBISET LINE WHEN TREATMENT STARTED. 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.

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED FORTY-FIVE MINUTES INTO TREATMENT (AT 06:31AM) THE COMBISET BLOODLINE WAS NOTICED TO BE COLLAPSED AFTER THE BLOOD PUMP SET SEGMENT. TREATMENT WAS INTERRUPTED, ONLY THE ARTERIAL BLOOD WAS RETURNED, AND NEW LINES WERE SET UP. AT 8:03AM THE PATIENT'S BLOOD PRESSURE (BP) DROPPED TO 63/33 AND THE PATIENT REPORTEDLY WAS SWEATING AND HAVING CHILLS. THE ULTRAFILTRATION (UF) WAS TURNED OFF AND THE PATIENT'S HEAD WAS TILTED BACK. THE UF REMAINED OFF FOR THE TREATMENT AND THE MEDICAL DIRECTOR (MD) WAS NOTIFIED. THE PATIENT ENDED TREATMENT EARLY, WAS STABLE AT DISCHARGE AND LEFT AMBULATORY WITH A STANDING BLOOD PRESSURE OF 136/66. UPON FOLLOW-UP, THE CM REPORTED A HEMODIALYSIS (HD) PATIENT WAS 45 MINUTES INTO DIALYSIS TREATMENT WHEN IT WAS REPORTED THE COMBISET BLOODLINE HAD A COLLAPSED TUBING AFTER THE BLOOD PUMP SEGMENT. TREATMENT WAS HALTED. THE CM CONFIRMED THAT THE MACHINE WAS NOT AFFECTED OR REMOVED FROM SERVICE AND THE BLOOD PUMP ROTOR WAS ORIGINAL TO THE MACHINE. NO FURTHER DAMAGE AND/OR DEFECTS WERE NOTED. A FRESENIUS DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS ABLE TO BE RETURNED FROM THE ARTERIAL SIDE. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 100 ML. THE CM STATED THE PATIENT WAS HYPOTENSIVE BUT INDICATED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH A NEW DIALYZER AND TUBING LINES 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: 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-CONFORMANCE'S 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 FORTY-FIVE MINUTES INTO TREATMENT (AT 06:31AM) THE COMBISET BLOODLINE WAS NOTICED TO BE COLLAPSED AFTER THE BLOOD PUMP SET SEGMENT. TREATMENT WAS INTERRUPTED, ONLY THE ARTERIAL BLOOD WAS RETURNED, AND NEW LINES WERE SET UP. AT 8:03AM THE PATIENT'S BLOOD PRESSURE (BP) DROPPED TO 63/33 AND THE PATIENT REPORTEDLY WAS SWEATING AND HAVING CHILLS. THE ULTRAFILTRATION (UF) WAS TURNED OFF AND THE PATIENT'S HEAD WAS TILTED BACK. THE UF REMAINED OFF FOR THE TREATMENT AND THE MEDICAL DIRECTOR (MD) WAS NOTIFIED. THE PATIENT ENDED TREATMENT EARLY, WAS STABLE AT DISCHARGE AND LEFT AMBULATORY WITH A STANDING BLOOD PRESSURE OF 136/66. UPON FOLLOW-UP, THE CM REPORTED A HEMODIALYSIS (HD) PATIENT WAS 45 MINUTES INTO DIALYSIS TREATMENT WHEN IT WAS REPORTED THE COMBISET BLOODLINE HAD A COLLAPSED TUBING AFTER THE BLOOD PUMP SEGMENT. TREATMENT WAS HALTED. THE CM CONFIRMED THAT THE MACHINE WAS NOT AFFECTED OR REMOVED FROM SERVICE AND THE BLOOD PUMP ROTOR WAS ORIGINAL TO THE MACHINE. NO FURTHER DAMAGE AND/OR DEFECTS WERE NOTED. A FRESENIUS DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS ABLE TO BE RETURNED FROM THE ARTERIAL SIDE. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 100 ML. THE CM STATED THE PATIENT WAS HYPOTENSIVE BUT INDICATED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH A NEW DIALYZER AND TUBING LINES WITHOUT FURTHER ISSUE. THE COMPLAINT DEVICE WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: A1, A2, A3, A4, B5.