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 11/30/2017 |
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 biomedical engineer (biomed tech) reported a dialyzer was leaking at the beginning of the hemodialysis (hd) patient's treatment once blood touched the dialyzer.No defect/damage observed to the dialyzer or its packaging was noted, and an internal blood leak was visually observed at the head of the dialyzer.No blood test strips were used.The patient was able to successfully complete hd treatment with new supplies on the same machine.The sample was discarded.
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Event Description
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A biomedical engineer (biomed tech) reported a dialyzer was leaking at the beginning of the hemodialysis (hd) patient's treatment once blood touched the dialyzer.No defect/damage observed to the dialyzer or its packaging was noted, and an internal blood leak was visually observed at the head of the dialyzer.No blood test strips were used.The patient was able to successfully complete hd treatment with new supplies on the same machine.The sample was discarded.
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Manufacturer Narrative
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Corrected occupation: biomedical engineer.Plant investigation: 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 reported complaint.The lot passed all release criteria.
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Event Description
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A biomedical engineer (biomed tech) reported a dialyzer was leaking at the beginning of the hemodialysis (hd) patient's treatment once blood touched the dialyzer.No defect/damage observed to the dialyzer or its packaging was noted, and an internal blood leak was visually observed at the head of the dialyzer.No blood test strips were used.The patient was able to successfully complete hd treatment with new supplies on the same machine.The sample was discarded.
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Manufacturer Narrative
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Corrective data: event date in follow up 2 is (b)(6) 2018.
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Event Description
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A biomedical engineer (biomed tech) reported a dialyzer was leaking at the beginning of the hemodialysis (hd) patient's treatment once blood touched the dialyzer.No defect/damage observed to the dialyzer or its packaging was noted, and an internal blood leak was visually observed at the head of the dialyzer.No blood test strips were used.The patient was able to successfully complete hd treatment with new supplies on the same machine.The sample was discarded.
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Search Alerts/Recalls
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