MARS

Additional Manufacturer Narrative

H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, TWO PICTURES WERE RECEIVED AND EVALUATED. ON INSPECTION, BLOOD WAS OBSERVED ON THE TUBING LINE (UNIT 1) IN THE ALBUMIN CIRCUIT. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

THIS REPORT WAS RECEIVED FROM MEDWATCH REPORT: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT UPON INITIATION OF THERAPY WITH A MARS KIT, A PINK TINGE WAS OBSERVED IN THE ALBUMIN. THE PINK TINGE WAS A RESULT OF A BLOOD LEAK INTO THE ALBUMIN CIRCUIT. A BLOOD LEAK ALARM WAS TRIGGERED. THE THERAPY WAS IMMEDIATELY STOPPED, HOWEVER, THE BLOOD WAS NOT RETURNED TO THE PATIENT. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF PACKED RED BLOOD CELLS, DUE TO A DROP IN HEMOGLOBIN "BELOW CRITICAL CARE STANDARDS" AND THE LOSS OF BLOOD IN THE MARS SET. THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.