Catalog Number 08-4000-LB |
Device Problems
Nonstandard Device (1420); Insufficient Information (3190)
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Patient Problems
Cardiac Arrest (1762); Death (1802); Sepsis (2067); Septic Shock (2068); No Code Available (3191)
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Event Date 04/01/2014 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).A field corrective action was taken for this type of complaint for this product as alleged.However, product-specific information was not provided to confirm whether this product was one of the recalled lots.Additional information has been requested and will be submitted upon receipt accordingly.
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Event Description
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The subject adverse event was reported via a lawsuit.The plaintiff's attorney alleged that the patient was delivered the product for use in hemodialysis at home three days a week.Shortly after beginning dialysis at home, the patient was admitted to the hospital; it was determined that the patient was experiencing (b)(6).The patient was discharged from the hospital four days after admission and resumed dialysis.After resuming dialysis the patient experienced sepsis, septic shock and expired from cardiac arrest eleven days after the initial hospitalization, all of which is alleged to have been caused by being exposed to the product (alleged to have bacterial contamination).
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Manufacturer Narrative
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(b)(4).Updated narrative after device evaluation: the product has not been returned for analysis and the product model and lot numbers were not made available.Investigation was conducted for retained samples on lots against which similar allegations have been made.Retains were tested for microbiological contamination (bioburden); the retains were found to be above the current specification for bioburden (<100 cfu/ml).Although medical records pertaining to this event including the death certificate and, if completed, autopsy report were requested, no further information regarding the reported event is available and a clinical investigation could not be performed.Without the requested additional information and clinical investigation, no conclusion can be drawn.Additional information has been requested and will be submitted upon receipt accordingly.
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Search Alerts/Recalls
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