Additional Manufacturer Narrative · 1
THIS FACILITY FIRST REPORTED ON A DIFFERENT CATALOG # (MFG REPORT 1221251-2007-9). WHEN THE SAMPLES WERE REC'D, AND REC'D A RESPONSE FROM THE REPORTER, IT WAS DISCOVERED THAT THERE WERE ACTUALLY TWO CATALOG NUMBERS INVOLVED. EVAL: INVESTIGATION: THE TWO D-60HL SETS INVOLVED WITH THE EVENT WERE TESTED BY THE MFR. FLUID TESTING: IN AN ATTEMPT TO DETERMINE IF THE CIRCULATING WATER FLOWS INTO THE CIRCUIT, THE RETURNED SET WAS CONNECTED TO THE FAST FLOW FLUID WARMER, MODEL 1000. THE MACHINE WAS TURNED ON FOR 5 MINUTES. ACCEPTANCE CRITERIA: THE HEATED WATER SHOULD FLOW FREELY THROUGH THE WATER PATH OF THE SET. RESULTS SAMPLE A: THE WATER TEMPERATURE INCREASED 40 DEGREES C FOR 5 MINUTES WHICH IS NORMAL. THE WATER FLOWED SLOWLY THROUGH THE SET WATER PATH, BECAUSE OF THE 6" AND 10" TUBES WERE KINKED AND NEEDED TO BE STRAIGHTENED OUT FOR IT TO RUN AT NORMAL FLOW. THE ALARM SYSTEM WAS NOT ACTIVATED; THEREFORE, THE SET PASSED THE FUNCTIONAL TEST. RESULTS SAMPLE B: THE WATER TEMPERATURE INCREASED 40 DEGREES C FOR 5 MINUTES WHICH IS NORMAL. THE WATER FLOWED THROUGH THE SET WATER PATH. THE ALARM SYSTEM WAS NOT ACTIVATED; THEREFORE, THE SET PASSED THE FUNCTIONAL TEST. VISUAL INSPECTION: ACCEPTANCE CRITERIA: THE PRODUCT SHALL NOT BE DAMAGED OR DISTORTED, AND THE TUBE SHALL NOT BE KINKED. THE CLAMPS SHALL WORK PROPERLY. RESULTS SAMPLE A: THE 6" TUBE FROM HEAT EXCHANGER TO FILTER AND THE 10" TUBE FROM HEAT EXCHANGER TO DRIP CHAMBER ARE KINKED AND NEEDED TO BE STRAIGHTENED OUT FOR IT TO RUN AT NORMAL FLOW. THE CLAMPS WORK PROPERLY. THE SAMPLE FAILED THE VISUAL INSPECTION. RESULTS SAMPLE B: NO TUBE DISCREPANCIES WERE OBSERVED. IT WAS OBSERVED THAT THE CLAMPS ASSEMBLED ON THE SET ARE DIFFICULT TO CLOSE AND DO NOT WORK PROPERLY; THE CLAMPS ARE DEFECTIVE. THE SAMPLE FAILED THE VISUAL INSPECTION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS THE USER FACILITY DID NOT RECORD THE LOT NUMBER OF THE DEVICE. IT WAS DETERMINED THAT NO FURTHER ACTION IS NECESSARY AS THE VISUAL FAULT NOTED ABOVE DID NOT AFFECT THE FLOW PATH OF THE RETURNED SAMPLES; AND MAY HAVE BEEN A REFLECTION OF HOW THE PRODUCT WAS RETURNED FOR EVAL.