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Received Feb 5, 2008 · Event occurred Jan 22, 2008
Report 1010493 · MDR key 1010493
Device
Generic name
Dialysis Machine, Crrt
Manufacturer
Gambro Renal Products, Inc.Model number
*Catalog number
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Lot number
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Product problems
- Alarm, audible
- Fluid/Blood Leak
- Component Missing
Patient
47 YR
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
PATIENT ON CRRT; DISCONTINUED THREE DAYS LATER WHEN HER RENAL FUNCTION IMPROVED. HOWEVER, SHE AGAIN SHOWED SIGNS OF RENAL FAILURE ONE WEEK LATER, AND HER URINE OUTPUT FELL. SHE WAS PLACED BACK ON CRRT AND REMAINED ON IT FROM THAT POINT. DURING THE DAY SHIFT 9 DAYS LATER, IT WAS NOTED BY THE NURSE THAT A SCREW WAS MISSING FROM THE REPLACEMENT FLUID HANDLE. OUR HOSPITAL CONTRACTS WITH AN OUTSIDE DIALYSIS COMPANY TO PROVIDE SERVICE TO OUR PATIENTS, BUT THE HOSPITAL STAFF NURSES PROVIDE INPATIENT DIALYSIS CARE TO THE ICU PATIENTS WITH EQUIPMENT FROM THE OUTSIDE COMPANY. THE HOSPITAL NURSE ASKED THE VENDOR'S NURSE FOR A REPLACEMENT CRRT MACHINE BUT NO OTHER MACHINE WAS AVAILABLE. THERE WERE NO APPARENT PROBLEMS ENCOUNTERED UNTIL EARLY MORNING ONE DAY LATER, WHEN THE MACHINE ALARMED SEVERAL TIMES THAT THE REPLACEMENT WEIGHT WAS WRONG. SEVERAL ATTEMPTS WERE MADE TO ALINE THE REPLACEMENT BAG. AFTER SEVERAL ATTEMPTS, THE MACHINE STATED THERE WAS A GREATER THAN 200 ML FLUID LOSS AND THE TREATMENT ENDED. THE PHYSICIAN WAS NOTIFIED.