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
Fever (1858); Unspecified Infection (1930)
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Event Date 05/03/2016 |
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).A patient was admitted to the facility with a right upper extremity peripherally inserted central catheter (picc) in place.The patient went to the cardiac catheterization lab where a left internal jugular pulmonary artery (ijpa) line and iabp were placed.The patient¿s picc line remained in place and the patient was transferred post-procedure to the cardiac care unit (ccu).Ten days later, the patient returned to the cardiac catheterization lab where the left ij pa was removed and another left ij pa was placed via a new stick.The following day, the patient developed a temperature of 38.5 centigrade and blood cultures were peripherally drawn.On the same day, the picc line was removed.The next day, the left ij pa and right iabp were replaced with a right subclavian pa and left iabp in the cardiac catheter lab.On an unspecified date, 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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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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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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