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Device Problem
Device Alarm System (1012)
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Patient Problems
Dyspnea (1816); Low Oxygen Saturation (2477)
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Event Date 05/31/2022 |
Event Type
malfunction
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Event Description
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It was reported that a spontaneous, remunity remote has had an occlusion alarm.There were no kinks in the tubing.The patient last changed infusion site two days ago.It was recommended that the patient change the site due to timing.The patient had trouble breathing with oxygen saturation lower than normal.It was recommended that the patient use oxygen as well as previous instruction of changing infusion site.The dose or amount: 39.76 ng/kg/min.The patient was able to switch to backup product with infusion continuing.The infusion is life-sustaining.
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Manufacturer Narrative
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Device evaluation: the device was not returned for analysis.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.Device details are unknown.Operator of device is patient/consumer.
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Manufacturer Narrative
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Other text: h4: device manufacture date could not be completed due to lack of information regarding lot number.H10: device evaluation: the device was not returned for investigation, so no visual inspection and functional test were performed.Because no product was returned, the investigator was unable to confirm the reported complaint.If the product is returned however, the manufacture will reopen this complaint for further investigation.No lot number was provided; therefore, device history record review could not be completed., corrected data: correction: product code: fpa.
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Manufacturer Narrative
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Other, other text: h4: device manufacture date could not be completed due to lack of information regarding lot number.H6: event problem and evaluation codes: updates not required.H10: device evaluation: the device was not returned for investigation, so no visual inspection and functional test were performed.Because no product was returned, the investigator was unable to confirm the reported complaint.If the product is returned however, the manufacture will reopen this complaint for further investigation.No lot number was provided; therefore, device history record review could not be completed., corrected data: d4: correction: product code: fpa.
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Search Alerts/Recalls
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