BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (HF); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 107140 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/13/2023 |
Event Type
Death
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Manufacturer Narrative
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Initial reporter address (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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In the patient bed and a disconnection between the prismaflex set and a non-baxter jocath catheter was observed.It was further reported the patient experienced desaturation with progressive hypotension, extreme bradycardia, and asystole.Cardiopulmonary resuscitation was started (total 34 min), subsequently the patient passed away.The cause of death was not reported.It was not reported if an autopsy was performed.After the event, it was found that the return line with an attached 3-step key (3 way stop cock) was disconnected from the patient¿s access, resulting in external blood loss.The amount of blood lost was unknown; however, based on time of disconnection (2-3 minutes and blood flow rate of 260 ml/ min) it was estimated at 520-780ml.No additional information is available.
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Manufacturer Narrative
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Correction: b5, inadvertently, the first sentence of the previously submitted b5 was missing.B5: it was reported that during continuous renal replacement therapy with a prismaflex hf1000 set, blood in the patient bed and a disconnection between the prismaflex set and a non-baxter jocath catheter was observed.It was further reported the patient experienced desaturation with progressive hypotension, extreme bradycardia, and asystole.Cardiopulmonary resuscitation was started (total 34 min), subsequently the patient passed away.The cause of death was not reported.It was not reported if an autopsy was performed.After the event, it was found that the return line with an attached 3-step key (3 way stop cock) was disconnected from the patient¿s access, resulting in external blood loss.The amount of blood lost was unknown; however, based on time of disconnection (2-3 minutes and blood flow rate of 260 ml/ min) it was estimated at 520-780ml.No additional information is available.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: 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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