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Model Number FLT-100 |
Device Problem
Use of Device Problem (1670)
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Patient Problems
Pulmonary Edema (2020); Hypervolemia (2664); Unspecified Kidney or Urinary Problem (4503)
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Event Date 06/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.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.
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Event Description
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It was reported that on june 17th during a fluent procedure, the fluid deficit quickly augmented reaching a deficit of 2500 ml, the fluent console stopped the inflow and alerted the physician about reaching the limit for 2500 ml, then the physician decided to continue with the procedure by resetting the fluid deficit to zero.After the procedure, the patient was low on oxygen and presented with fluid in her lungs and blood in her urine which prompted the staff to admit her to the emergency room.No other information is available.
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Manufacturer Narrative
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Device was received, visual inspection was performed, and it was found that the tubbing for the device was cut, external evaluation showed no issues with the device, functional testing could not be performed due to the tubbing being cut.No other information is available.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.
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Search Alerts/Recalls
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