BAXTER HEALTHCARE CORPORATION RADIATION STERILIZED EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number EMC0062M |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that an extension set had split and the patient did not receive the prescribed volume.This was observed during patient infusion of parenteral nutrition.The patient was prescribed 500ml; however, the patient had a deficit of 477ml.To resolve the event, the patient was connected to parenteral nutrition again with no further issues.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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Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H4: device manufactured on an unknown date in may 2022.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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Search Alerts/Recalls
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