OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 0500318E |
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 11/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Plant investigation: although it was originally stated that the complaint device was available to be returned to the manufacturer for evaluation, no samples have been received as of this time.Therefore, the reported complaint was not confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There was one approved temporary deviation notice (dn) noted on the lot, which was unrelated to the reported event.There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event.The review included a check of non-conformances, rework, labeling, process controls, and any other occurrence in production potentially related to the complaint.The lot passed all release criteria.A review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.
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Event Description
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A user facility clinic manager reported that a dialyzer blood leak occurred approximately one hour after initiation of the patient's hemodialysis (hd) treatment.The machine alarmed for blood leak.Blood was not visually observed.Blood test strips were used and positively confirmed the presence of blood.No dialyzer defect or damage was observed.The patient¿s estimated blood loss (ebl) was noted as being approximately 300ml as the patient¿s blood was not returned.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient was given prophylactic antibiotics only.The clinic manager stated that the dialyzers are currently being stored on the floor on a cart and stated that she does not know if people are walking into the cart and dropping them.The complaint device was stated to be available to be returned to the manufacturer for evaluation.
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Manufacturer Narrative
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Device evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination of the returned device noted that the fiber bundle was wet and revealed the presence blood exposure.Gross visual examination of the returned device did not identify any damage or irregularity to the fiber bundle or any of the molded components.There were no kinked, broken, looped, or damaged fibers on the circumference of the fiber bundle.The polyurethane (pu) material was distributed evenly and was noted to be intact, without any visually identifiable inconsistency.The dialyzer was subjected to a laboratory bubble point test and no leaks were observed.The returned device was also sent for destructive disassembly to better visually examine the pu cut surfaces.The visual examination of the pu cut surfaces noted that both ends were intact and there was no visual damage, irregularities, or separations identified.The fiber bundle was then removed from the dialyzer housing to better inspect the inferior pu surface and fiber bundle.Subsequent visual examination did not identify any damage or irregularities.There were no kinked, looped, or damaged fibers observed.Further visual examination did not identify any voids.The investigation into the cause of the reported problem was not able to confirm the reported leak.The testing of the returned sample could not reveal a probable cause for the customer complaint.Therefore, the complaint is not confirmed.
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