BAXTER HEALTHCARE CORPORATION AMIA AUTOMATED PD CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number 5C5479 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/23/2023 |
Event Type
malfunction
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Event Description
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It was reported that a patient experienced air in the patient line of two (2) amia automated pd cycler sets.During the initial drain of peritoneal dialysis (pd) therapy, multiple air bubbles were observed in the tubing.Renal therapy services (rts) assisted the patient with starting therapy over.After completing the cassette test and priming, air bubbles were again observed within the patient line and solution lines.The patient was connected for therapy at the time of this event.Rts advised to end the therapy session and continuous ambulatory peritoneal dialysis was discussed.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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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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