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: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.D4, g5, h4: lot and item number unavailable at time of reporting.
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Event Description
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It was reported that there was an increase in the number of complaints related to leaking of the extension set.Per reporter sixty-seven (67) patients were affected between january to june, 2023.No major patient injury issues were reported but some patients mentioned exhibiting pulmonary arterial hypertension symptoms.
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Manufacturer Narrative
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Other text: no product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.
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Search Alerts/Recalls
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