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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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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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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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Manufacturer Narrative
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No lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.D4: catalog number, udi number, and lot number, and expiration date are unknown; g5: 510k is unknown; h4: device manufacture date is unknown.
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Search Alerts/Recalls
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