OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 0500316E |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Blood Loss (2597)
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Event Date 09/22/2020 |
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 an internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak was not visually observed in the dialyzer.A blood test strip was used to test for the presence of blood, and the result was positive.It was confirmed that the machine, a fresenius 2008 k , alarmed appropriately with a blood leak alert.Streamline bloodlines were used for the treatment.No damage was identified on the dialyzer.After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was reported to be less than 100 ml.Follow-up with the clinic¿s facility administrator confirmed there was no patient injury, no adverse events, and no medical intervention as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on the same machine.The dialyzer was not available to be returned for evaluation as it was reportedly discarded.
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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.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
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