Device Problem
Application Program Problem: Dose Calculation Error (1189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report has been identified as b.Braun medical, inc.Internal report number (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.
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Event Description
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As reported by the user facility: brief inquiry description: incorrect national drug code (ndc) in delivery factor development.Detailed inquiry description: customer requested delivery factors (df) for a heparin dilution compounded at their facility.The product sent to the b.Braun medical inc.(bbmi) carrolton facility was labeled as heparin in 0.45% normal saline (ns) (b)(4) units per milliliter (units/ml).The heparin dilution was compounded using ndc 63323-276-01, a conventionally manufactured heparin sodium (b)(4) units/2 ml ((b)(4) units/ml).The df request identified the heparin solution as ndc 63323-276-01 which was the same as the ndc noted on the df barcode sheet.However, the apex compounding systems uses ndcs to identify solutions and determine dfs.Without a unique ndc, the apex system would not be able to distinguish between concentrated conventionally manufactured solutions and the customer's heparin dilutions.
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Manufacturer Narrative
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This report has been identified as b.Braun medical, inc.Internal report number (b)(4).The device was not returned for evaluation, and the device logs were not made available.Further investigation of the complaint is not possible without a device for evaluation or the device logs.If the device or the device logs do become available, the complaint will be reopened for further evaluation.All information concerning this reported incident has been included in our trend analysis of the product line.
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Search Alerts/Recalls
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