CONCORD MANUFACTURING CRIT-LINE CLIP (CLIC) - USB; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
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Catalog Number CL10041001 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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Event Description
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A user facility biomedical technician (bmt) reported to technical support that a clic crit-line clip won't calibrate and caused the circuit board to burn out.Upon follow-up, the bmt stated the there were no diagnostic messages or audible alarms.The bmt stated there was no patient involvement, patient harm, or adverse event reported.The bmt stated the circuit board appeared burnt and confirmed there was no smoke, fire or burning smell as associated with the reported event.The bmt replaced the circuit board to resolve the reported issue.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and does not have a previous history of failing an electrical leakage test.The replaced component was returned for investigation.
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Event Description
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A user facility biomedical technician (bmt) reported to technical support that a clic crit-line clip won't calibrate and caused the circuit board to burn out.Upon follow-up, the bmt stated the there were no diagnostic messages or audible alarms.The bmt stated there was no patient involvement, patient harm, or adverse event reported.The bmt stated the circuit board appeared burnt and confirmed there was no smoke, fire or burning smell as associated with the reported event.The bmt replaced the circuit board to resolve the reported issue.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and does not have a previous history of failing an electrical leakage test.The replaced component was returned for investigation.
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Manufacturer Narrative
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Additional information: d9, h3 plant investigation: exterior inspection revealed corrosion on the interior and exterior of the usb connector.Thermal damage was not observed on the usb connector.The clic device had no other damage.Power-on test failed (clm iv).The returned clic device failed to power on when attached to a clm iv.The wires of the usb cable passed a continuity test.Internal inspection found no discrepancies, none of the clic¿s circuit boards had thermal damage.Due to the power failure, the clic device could not be tested for the reported calibration problem.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be traced to component failure.
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