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Model Number 21-7106-24 |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354); Product Quality Problem (1506)
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Patient Problem
Pulmonary Hypertension (4460)
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Event Date 05/08/2023 |
Event Type
malfunction
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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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Event Description
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It was reported the disposable leaked at the filter.The patient, with pulmonary hypertension, was taking the medicine veletri,.The patient did not communicate the time of the incident, he stated that felt wet after a while, before arriving on time.There was no injury or harm.
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Manufacturer Narrative
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H6 evaluation codes: updated 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.If the product is returned, the manufacturer will reopen this complaint for further investigation.No serial number was provided; therefore, a device history record (dhr) review could not be conducted.
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Manufacturer Narrative
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Other text: d3, g1, g2 email address: (b)(6) corrected data: h10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
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Search Alerts/Recalls
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