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
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/03/2020 |
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 clinical manager (cm) reported that an internal dialyzer blood leak occurred approximately one hour into a patient¿s hemodialysis (hd) treatment.The blood leak was visible in the dialysate compartment of the device, and in the dialysate line.A blood test strip was used and tested positive for the presence of blood.It was confirmed that the machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.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 250 ml.The cm confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was reportedly available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received.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.Should the sample be returned at a later date, a supplemental report will be submitted capturing the updated investigation results.
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