OGDEN MANUFACTURING PLANT OPTIFLUX F250NRE DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 0500325E |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 03/18/2024 |
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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It was reported that an internal dialyzer blood leak occurred at the start of a patient¿s hemodialysis (hd) treatment, approximately three to five minutes after initiation.The blood leak was not visually observed.The machine, a baxter artis, alarmed appropriately with a blood leak alarm.The dialysate was tested with a blood leak test strip, and it tested positive.No physical damage or defects were noted on the dialyzer.The patient¿s blood was not returned.Estimated blood loss (ebl) due to the event was 300 ml.There was no patient injury, adverse event, or medical intervention required due to the event.The patient was able to complete their treatment after being re-setup with new supplies on the same machine.The dialyzer was not available to be returned for manufacturer evaluation as it was reportedly discarded.Photos of the dialyzer were also unavailable.
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Manufacturer Narrative
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Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.Furthermore, a device lot number was not provided and the customer account number is not known.Therefore, a shipping history search could not be performed in sap.As such, a production records review was not performed, and the device history records (dhr) could not be investigated.Based on the information available, a definitive conclusion regarding the complaint incident cannot be reached.
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Event Description
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It was reported that an internal dialyzer blood leak occurred at the start of a patient¿s hemodialysis (hd) treatment, approximately three to five minutes after initiation.The blood leak was not visually observed.The machine, a baxter artis, alarmed appropriately with a blood leak alarm.The dialysate was tested with a blood leak test strip, and it tested positive.No physical damage or defects were noted on the dialyzer.The patient¿s blood was not returned.Estimated blood loss (ebl) due to the event was 300 ml.There was no patient injury, adverse event, or medical intervention required due to the event.The patient was able to complete their treatment after being re-setup with new supplies on the same machine.The dialyzer was not available to be returned for manufacturer evaluation as it was reportedly discarded.Photos of the dialyzer were also unavailable.
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Search Alerts/Recalls
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