Catalog Number 106697 |
Device Problem
Disconnection (1171)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The patient's age was reported as "over 80 years old".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 renal replacement therapy (crrt) using a prismaflex control unit and a prismaflex m100 set, the return blood line dislodged from the set, specified as ¿from the upper part of the filter¿.The event occurred four hours into treatment after an unknown alarm was generated.The extracorporeal blood was not returned to the patient.A blood loss of approximately 152 ml occurred.Treatment was discontinued.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The actual device was not available; however, photographs of the sample were provided for evaluation.The visual inspection of the provided pictures shows that the return line is disconnected from the screwed connector during use.The reported condition was verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.As the actual device was not returned, the cause for the reported issue could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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