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Device Problem
Device Alarm System (1012)
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Patient Problems
Diarrhea (1811); Dyspnea (1816); Blurred Vision (2137)
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Event Date 08/18/2022 |
Event Type
malfunction
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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.No information has been provided to date.
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Event Description
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It was reported that the patient wasted 2 partially used cassettes due to a no disposable alarm.The patient was without medication for one hour, and short of breath with blurry vision.After the patient's spouse started the infusion with the medication again, the patient experienced diarrhea.The patient reported that was feeling fine at the time after when the report was made.No patient injury or severe adverse events were reported.
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Manufacturer Narrative
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No product or photographic evidence was provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use ifu or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, the complaint will be reopened for further investigation.No lot or serial number was provided therefore, a device history record dhr review could not be performed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Search Alerts/Recalls
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