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)
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Event Date 08/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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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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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).A patient was admitted to the hospital and was treated for an unrelated indication.Six days after the patient was admitted, the patient became febrile and the patient was transferred to surgical intensive care unit (sicu) with concern for sepsis.Three day later, redness at the port site was noted so the port was removed and replaced with a peripherally inserted central catheter (picc) line.On the same day, the patient was discharged home and the patient was treated with unspecified (reported as ¿appropriated¿) antibiotics for clabsi (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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A product use review was conducted with the hospital by baxter clinical services.The assessment revealed that scrubbing (antiseptic) of the device was not performed according to the package label instructions.It was stated in the assessment result, that ¿no scrubbing was performed when the device was removed from the packaging and in between multiple syringe accesses¿.Upon further review, it was determined that the reported condition of ¿central line associated blood stream infection (clabsi)¿ was due to use error and therefore, not a manufacturing related issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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