BAXTER HEALTHCARE - AIBONITO ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 7N8399 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Fever (1858); Chills (2191)
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Event Date 01/30/2016 |
Event Type
Injury
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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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Event Description
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A patient experienced a central line associated blood stream infection (clabsi) which was reported to be due to a one-link neutral luer activated device (no further detail was provided).The patient was admitted to the hospital to undergo a procedure for another indication.On the day of admittance, a right internal jugular (ij) line was placed which included the one-link device.On an unreported date, this line fell out despite stitches and the securing of the device.The ij line was replaced as a left ij line two days after being admitted to the hospital.Five days later, the patient became febrile with rigors.On an unreported date, the patient began treatment for the clabsi with unspecified (reported as ¿appropriate¿) antibiotics (doses, frequencies, and routes were not reported).No further detail was provided regarding the patient¿s outcome from the event.No additional information is available.
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Manufacturer Narrative
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As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The cause of the event was determined to be human error as the packaging instructions were not followed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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