Model Number 21-7302-24 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Dyspnea (1816); Low Oxygen Saturation (2477)
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Event Type
malfunction
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Event Description
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It was reported that the patient had 4 cassette which are affected by the medical device correction.The patient reported she had been getting "no disposable attached" alarm and for the past two days increased shortness of breath and lower oxygen level.The patient was advised to mix a new cassette using unaffected cassettes.The patient was able to continue infusion with backup cassette.
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Manufacturer Narrative
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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 reportable information becomes available.
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Manufacturer Narrative
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Other, other text: b5: additional information received via email from customer on (b)(6)2022 and attached by to complaint object: number of cassettes replaced due to no disposable attached alarm is unknown/unspecified.Date of events are unknown/unspecified, pharmacy date of awareness was (b)(6)2022.Outcome of events: ongoing at time of event.Will request pharmacy reach out to patient to confirm if product is available for return and provide update once available.B5: additional information received via email from customer on (b)(6)-2022 and attached to complaint object: number of cassettes for evaluation not specified, pharmacy following up with patient.H6: event problem and evaluation codes: updates not required.H10: device evaluation including root cause analysis is in progress.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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Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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.
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Search Alerts/Recalls
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