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Model Number 21-7106-24 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Pulmonary Hypertension (4460)
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Event Date 01/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported the disposable exhibited a leak with male/male luer, 0.2-micron air-eliminating filter, integral anti-siphon valve, and clamp.It was reported some patients exhibited pah symptoms.No further information provided.
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Manufacturer Narrative
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Other, other text: no product was returned.The reported complaint could not be confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.If the product is returned this complaint will be reopened for further investigation.
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Search Alerts/Recalls
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