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 12/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental medwatch report will be submitted upon completion of the investigation.
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Event Description
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A registered nurse (rn) from a user facility reported of a blood leak from the dialyzer.The machine alarmed with blood backed up into the hansen connector.Additional follow-up information received revealed the hd patient was on the machine just a few minutes before major blood leak was noted, and blood reportedly had entered dialyzer and alarm started on machine, blood backed up into hanson hoses, and the machine was stopped.The hd patient was taken off the machine without blood being given back to him and the patient finished treatment on another machine.No problems were noted and no medical attention was required.The biomed was notified and dialysis machine was cleaned per biomed per proctocol.The sample was available to be returned for evaluation.
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Event Description
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A registered nurse (rn) from a user facility reported of a blood leak from the dialyzer.The machine alarmed with blood backed up into the hansen connector.Additional follow-up information received revealed the hd patient was on the machine just a few minutes before major blood leak was noted, and blood reportedly had entered dialyzer and alarm started on machine, blood backed up into hanson hoses, and the machine was stopped.The hd patient was taken off the machine without blood being given back to him and the patient finished treatment on another machine.No problems were noted and no medical attention was required.The biomed was notified and dialysis machine was cleaned per biomed per proctocol.Additional information provided from the rn revealed there were no signs of any defect or damage to the dialyzer or its packaging prior to use, and the blood leak was seen once by staff any myself backing up into the hanson lines.Per rn the dialysis machine did alarm major blood leak alarm at the time, and the blood was noted to go through the hanson and was coming out the drain holes in the wall of the bicarb/acid ports on the wall.The biomedical engineer cleaned machine and blood strips were used per biomed, and the patient's blood flow rate was approximately 300 and the patient's dialysate flow rate was approximately 600.There was approximately 200-250cc blood lost.The sample was available to be returned for evaluation.
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Manufacturer Narrative
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Plant investigation: the complainant facility returned one f180nre dialyzer for manufacturer examination.During the gross visual examination of the sample, a separation was identified within the polyurethane potting near the outer perimeter of the fiber bundle on the cavity id end.The separation extended from approximately 90° to 150° with the dialysate ports at 0°.The separation was within the polyurethane and not a separation of the polyurethane (potting material) and the dialyzer housing (wall).There were no other defects or irregularities visually identified on the fiber bundle or any of the molded dialyzer components.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.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.The investigation into the cause of the reported problem was able to confirm the failure mode.There was a confirmed leak on the cavity id end of the dialyzer.The complaint has been deemed confirmed.
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Event Description
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A registered nurse (rn) from a user facility reported of a blood leak from the dialyzer.The machine alarmed with blood backed up into the hansen connector.Additional follow-up information received revealed the hd patient was on the machine just a few minutes before major blood leak was noted, and blood reportedly had entered dialyzer and alarm started on machine, blood backed up into hanson hoses, and the machine was stopped.The hd patient was taken off the machine without blood being given back to him and the patient finished treatment on another machine.No problems were noted and no medical attention was required.The biomed was notified and dialysis machine was cleaned per biomed per protocol.Additional information provided from the rn revealed there were no signs of any defect or damage to the dialyzer or its packaging prior to use, and the blood leak was seen once by staff any myself backing up into the hanson lines.Per rn the dialysis machine did alarm major blood leak alarm at the time, and the blood was noted to go through the hanson and was coming out the drain holes in the wall of the bicarb/acid ports on the wall.The biomedical engineer cleaned machine and blood strips were used per biomed, and the patient's blood flow rate was approximately 300 and the patient's dialysate flow rate was approximately 600.There was approximately 200-250cc blood lost.The sample was available to be returned for evaluation.
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