Catalog Number 107142 |
Device Problem
Disconnection (1171)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(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 treatment with a prismaflex hf1400 the pre blood pump bag was not connected securely and became disconnected, causing a significant amount of air to enter into the extracorporeal circuit leading to foam formation in the deaeration chamber.Blood was returned to the patient and the machine was placed into saline recirculation however, the deaeration chamber was almost completely filled with foam and the filter clotted alarm started occurring.The fluid level in the chamber was very low and the foam entered the monitor line and reached the transducer filter.There was a significant amount of foam in the circuit.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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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: removal of information in section f related to importer - the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).
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Search Alerts/Recalls
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