ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number UNKNOWN- FMC BLOODLINE |
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 05/08/2018 |
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 reported that during a patient hemodialysis (hd) treatment the fresenius 2008k2 machine had an unstable transmembrane pressure (tmp).It was reported that the patient was moved to another machine to complete treatment with new supplies.It was also reported that there was blood loss experienced by the patient.However, patient¿s estimated blood loss was unknown.It is unknown if there was any patient adverse event or medical intervention required.Additional information was solicited; however to date none has been received.
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Manufacturer Narrative
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The sample was not returned to the manufacturer and the lot number was not provided.Since there is no information of product, lot number, patient¿s alternate identifier and clinic; is not possible to obtain any potential lot delivered to the patient in order to retrieve alternate samples from distribution center for evaluation.Lot trend evaluation was not performed since the product and lot number are unknown and there is not information to a possible lot number from product fmc bloodline.No device history review was performed since there is not information of any lot number.
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Search Alerts/Recalls
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