CATHETERS SHORT TERM

Description of Event or Problem

IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY USING A GAMCATH CATHETER AND A PRISMAFLEX SET, THE PATIENT EXPERIENCED AN AIR EMBOLISM, HYPERTENSION, DESATURATION RATE OF 80%, DYSPNEA, AND A GLASGOW COMA SCALE OF 5. IT WAS REPORTED THAT AIR WAS VISIBLE FROM THE GAMCATH CATHETER TO THE PRISMAFLEX SET. TREATMENT WAS TERMINATED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. IT WAS REPORTED THE PATIENT RECEIVED "HYPERBARIC CHAMBER FOR GAS EMBOLISM". AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE SAMPLE DETERMINED THAT IT WAS A NON-VANTIVE CATHETER. BASED ON ADDITIONAL INFORMATION RECEIVED, THE GAMCATH CATHETER WAS DETERMINED NOT TO BE A FACTOR IN THE REPORTED ADVERSE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.