BAXTER HEALTHCARE CORPORATION PHOENIX/INNOVA MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 103453 |
Device Problem
Inadequate Ultra Filtration (1656)
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Patient Problem
Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 05/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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The device was not received for evaluation; however, it was inspected on-site by a baxter qualified technician.Visual inspection and functional tests showed that the hydraulic circuit of the involved phoenix machine was encrusted highly likely by salt crystal deposit and/or debris resulting from drying dialysate fluid.To resolve this situation, the technician performed descaling of the hydraulic circuit as per phoenix operator's manual - chapter 6 "clean/disinfect".This action was able to remove all the encrustation.After complete check including pressures reading, electrovalves test and calibration, they performed a treatment simulation with weight loss of 3 hours and a half without any problem and with an actual target weight loss (twl) equal to the programmed one.The machine was then returned to clinical use without any further similar event reported.The reported condition was verified.Based on the result of the technical inspection by baxter service technician, the cause of the excessive weight removal was confirmed to be the encrustation of the hydraulic circuit of the used phoenix machine.This encrustation was due to incorrect descaling/disinfection scheduling of this customer for this machine.Descaling with vinegar, citric acid or acetic acid is an important process to periodically perform to remove mineral deposits which can also reduce the effectiveness of the weight loss and of the disinfection process.Deposits and/or debris inside the flowmeters of the machine can lead to clog the gears in the flowmeters itself thus leading to error in the ultrafiltration mass balance system of the machine for incorrect flowmeters reading in such a situation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that during treatment with a phoenix machine, the machine ultrafiltered more than expected.The patient¿s pre-treatment weight was 64,2 kg, and the weight after treatment was 62,8kg, indicating that total weight loss (twl) was 1,4kg, while set twl was 0,5kg.The patient presented with cramps and a bolus of saline was administered (amount of bolus not reported).No additional information is available.
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