Catalog Number 113081 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Alternate telephone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that during continuous veno-venous hemodiafiltration (cvvhdf), using a prismaflex control unit, multiple alarms were generated which resulted in pediatric patient treatment termination without blood restitution.It was reported the effluent pressure sensor housing was cleaned, then a filter clotted alarm followed by a filter is clotting alarm were generated.Then a transmembrane pressure (tmp) too high alarm occurred.The reporter decreased the blood flow rate from 90 to 40.Subsequently a filter extremely positive alarm was generated.The reporter attempted to return the blood.The reporter aspirated/flushed the return side of the catheter before starting the blood return.The filter extremely positive and return extremely positive alarms occurred.The patient was disconnected and treatment was discontinued without blood restitution of extracorporeal circuit.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Additional information: h6 and h10.The device was not received for evaluation; therefore, a device analysis could not be completed.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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