Catalog Number 21-7302-24 |
Device Problem
No Flow (2991)
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Patient Problems
Nausea (1970); Dizziness (2194)
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Event Date 09/01/2023 |
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 the device system delivering intravenous (iv) treprostinil exhibited multiple no disposable clamp tubing' alarms.Per the reporter, the pump was working fine but the cassette was malfunctioning.The longest the patient was without medication was 33 minutes and the patient reported lightheadedness and nausea as a result of interruption to the therapy.No medical intervention was required.The patient was able to switch to another cassette and continue therapy.
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Manufacturer Narrative
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No product was returned.If the product is returned this complaint will be reopened for further investigation.Device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).
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Search Alerts/Recalls
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