BAXTER HEALTHCARE CORPORATION HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number L5C4531 |
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 01/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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G1 manufacturing facility - this device was manufactured at one of the two following manufacturing sites: baxter healthcare - mountain home 1900 n highway 201 mountain home, ar 72653 united states.Baxter healthcare - dominican republic carretera sanchez km 18.5, parque industrial itabo, piisa haina, san cristobal 91000 dominican republic.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 a homechoice automated pd set with cassette had a lot of air which resulted in an unspecified alarm.This occurred during use of peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event, however the patient was given prophylactic antibiotic treatment.No additional information is available.
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Manufacturer Narrative
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Additional information was added to h6 and h10.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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