BAXTER HEALTHCARE CORPORATION AMIA AUTOMATED PD CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number 5C5479 |
Device Problems
Protective Measures Problem (3015); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2023 |
Event Type
malfunction
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Event Description
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It was reported that a homechoice device experienced a low priority 30166 (max air exceeded) alarm.The patient was connected at the time of the alarm.This occurred during and unspecified process step of peritoneal dialysis therapy.During troubleshooting, there were no issues observed that led to this alarm.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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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction made to d4: expiration date: 06/19/2025 (previously submitted as ni).Correction made to d4: unique identifier (udi) #: (b)(4) (previously submitted as ni).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 discarded; 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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