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 Problems
Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/18/2020 |
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 visually observed in the dialyzer.A blood test strip was used to test for the presence of blood, and it tested positive.It was confirmed that the machine, a fresenius 2008 k2, alarmed appropriately with a blood leak alert.Fresenius bloodlines were used for the treatment.No damage was identified on the dialyzer.After the machine alarmed and the leak was observed the treatment was halted and lines were clamped.Follow-up with the clinic¿s charge nurse confirmed there was no patient injury, no adverse events were experienced, and no medical intervention was required as a result of the reported event.The patient did not complete their treatment after the reported event.The dialyzer was not available to be returned for evaluation as it was reportedly discarded.Patient information and estimated blood loss were not available.
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Manufacturer Narrative
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Corrected information: h6 patient code replaced (transcription error) 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, non-conformances, deviation, 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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