ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Model Number CUSTOM COMBI SET |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 field technical manger (ftm) reported an alarm and then a blood leak that occurred during the patient¿s hemodialysis (hd) treatment.There was no patient injury, adverse events, or medical intervention required as a result of this event.The machine was shut down, the bloodlines were replaced, and the patient successfully completed treatment.Upon follow up, the ftm confirmed that the patient experienced no impact and has been continuing treatments with no further issues or reoccurrence of the reported event.Additional information was requested, however was not provided.The complaint device was discarded and is not available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
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