Catalog Number UNKNOWN- FMC BLOODLINE |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Blood Loss (2597)
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Event Date 05/16/2018 |
Event Type
Injury
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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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It was reported that a patient did not connect the bloodline to the dialyzer properly therefore creating a blood leak.It is unknown how far long into treatment the blood leak occurred.The patient¿s estimated blood loss is unknown.Additional information received, stated that the leak was external and it was at the connection between the bloodline and the dialyzer.Additionally, the blood was visually observed on the floor.The patient ended up requiring blood transfusion (amount unknown).The patient has a dialysate flow rate (dfr) of 300 and blood flow rate (bfr) of 300.The complaint device is not available to be returned to the manufacturer fro physical evaluation.
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Manufacturer Narrative
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Clinical investigation: there is a temporal relationship between the patient blood loss and hemodialysis (hd) therapy on the 2008k@home machine, however, the patient reported that he did not properly connect the bloodline to the dialyzer which resulted in a blood leak directly causing the patient blood loss.There is no allegation that the 2008k@home machine malfunctioned or that there was any deficiency in performance.The cause of the blood loss is directly related to the improper connection by the patient the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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Manufacturer Narrative
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The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.A device history review was not performed since the lot number of the alleged device is unknown.
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Event Description
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Search Alerts/Recalls
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