Model Number AX1000 |
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 12/09/2020 |
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 investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
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Event Description
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As per reported by the user facility: the solution on line 20 changed from sodium phosphate to potassium phosphate in the apex system.There was no patient involvement.
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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 logs were provided for evaluation.The logs show that sodium phosphate was confirmed on station 20 and later a potassium phosphate ndc was scanned and confirmed on station 20.It was found that the two (2) solutions were marked as interchangeable in the database.Apex will allow solutions that are marked interchangeable to be switched on the same station throughout the day and when reconciling an order would allow the ordered volume to be filled by either interchangeable ingredient.To fix this, the user needs to go into either the sodium phosphate ingredient or the potassium phosphate ingredient and undo the interchangeability between the two.If additional pertinent information becomes available a follow-up report will be filed.
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Search Alerts/Recalls
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