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Model Number FW-300 |
Device Problems
Fire (1245); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received for evaluation and found to have signs of soot and burn marks consistent with involvement in a ¿high heat¿ event.The power cable was melted and fused to the external power entry module of the device.The inside of the fluid warmer was inspected and showed no evidence of corrosion or fluid ingress.The findings were consistent with fluid ingress into the power cable inlet and power entry module, causing a high resistance short between the ground and line terminals on the power plug.All devices must meet quality requirements and manufacturing specifications prior to release.The device meets requirements for electrical and safety standards as outlined in the user guide.The user guide contains a precaution to verify the fluid warmer and power cord show no sign of external damage prior to use.If the unit is damaged, follow the product return procedure described in this manual.It warns to plug the warmer into a properly grounded outlet and describes connection for the power cord from a grounded power outlet to the back of the warmer.Per the user guide proper electrical hookup in full compliance with all applicable codes and device specifications must be maintained.Details of the electrical connections or during use are unknown.Udi: (b)(4).
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Event Description
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A report was received on (b)(6) 2022 from the home therapy nurse (htn) of a 57 year old male patient with a medical history including end stage renal disease, stating the patient's express fluid warmer caught on fire during a home hemodialysis treatment on (b)(6) 2022.Additional information was received on 26 oct 2022 from the home therapy nurse (htn) who stated fluid had leaked onto the device approximately one hour into a hemodialysis treatment.Per the htn, there was no harm or adverse impact to the patient or user from the event.
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Search Alerts/Recalls
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