ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 03-2722-9 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/17/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodline products from the reported catalog number (03-2722-9) shipped to this account within the selected time frame.A records review was performed on all lots identified.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.
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Event Description
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A clinic manager (cm) from an in-center hemodialysis user facility reported a patient pulling out their venous blood line during treatment.Per cm, the patient had suffered a stroke in the past, so her mental status is impaired.This act was recognized immediately after the incident occurred, treatment was halted, and the patient was switched to a catheter and continued treatment with no adverse effects.The patient's estimated blood loss (ebl) was noted as being approximately 100cc.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The machine was evaluated for any potential malfunctions; none were found.The bloodline device was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.
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