BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number L5C4531 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the homechoice cassette appeared to not be welded properly.The patient opened the overpouch, inspected the cassette, and thought there was an issue with the welding between the patient line and the connector.The patient did not use the cassette for therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The device was received for evaluation.A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.A visual inspection was performed with the naked eye.Functional testing was performed which included leak testing, clear passage testing, clamp function testing, and device-device interaction testing.The reported problem was not verified because visual inspection and all functional testing were performed with no issues.The reported issue was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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