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: 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.
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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.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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