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Model Number FLT-100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypervolemia (2664)
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Event Date 03/30/2023 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2023, a myosure procedure was performed with a fluent system, and during the procedure, the fluid increased rapidly and the doctor decided to continue.The anesthesiologist started to see that the vitals were not good and had the doctor stop the procedure.The procedure was aborted.The patient was bloated and had clear signs of fluid absorption.The doctor tried using suction irrigation to remove the fluid from the patient.The total deficit was approximately 5000.It was unknown at this point if there was perforation.The patient was put on lasix and spent the night in the hospital for observation.No additional information is available.
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Manufacturer Narrative
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Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.D4: lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.H3: the device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.Additional device involved in this case: see 1222780-2023-00122.
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Search Alerts/Recalls
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