STERICHEK TOTAL CHLORAMINE AND RESIDUAL CHLORINE
Received Sep 3, 2008 · Event occurred Jul 14, 2008
Report 1153743 · MDR key 1153743
Device
Product problems
- False Reading From Device Non-Compliance
- Residue After Decontamination
Patient
64 YR
- Nausea
- Weakness
Narrative
Description of Event or Problem
MACHINE IN USE SEVERAL TIMES. WAS CLEANED/REVISED AND TEST FOR BLEACH SHOWED. ON 7/14 PATIENT CONDITION WORSENED WITHIN 10 MINUTES OF START OF DIALYSIS. AFTER RINSEBACK BLOOD LINE TURNED LIGHT BROWN. DRAIN LINE NEGATIVE FOR BLEACH; BLUE HANSON CONNECTOR AND I PRESSURE BLEACH. PATIENT TO ED THEN TCN FOR DIALYSIS, AND OVERNIGHT STAY. OUR FACILITY NOTIFIED OF HACH REAGENT STRIP RECALL ON 7/24 VIA A RENAL NETWORK. FALSE NEGATIVES AND POSITIVES BEING FOUND, THE REPORT SHOWS. NOT CLEAR WHAT CAUSE OF PATIENT'S CHANGE IN CONDITION. REAGENT STRIPS FAULTY. HOWEVER BLEACH EXPOSURE IS AMONG THE POSSIBILITIES. INCREASED LENGTH OF TUBING TO RINSE ALSO. DIALYSIS EQUIPMENT MANUFACTURERS NOTIFIED OF INCIDENT AND RESPONDED (FRESENIUS) CONNECTOR IS TWO STEP TO CLICK/SNAP. ALSO, POTENTIAL FOR BLEACH TO ACCUMULATE DURING "LAST PEDOWN".