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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. APEX; COMPOUNDER

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B. BRAUN MEDICAL INC. APEX; COMPOUNDER Back to Search Results
Model Number AX1000
Device Problem Application Program Problem: Dose Calculation Error (1189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
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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Brand Name
APEX
Type of Device
COMPOUNDER
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
1601 wallace drive, suite 150
carrollton TX 75006 6690
MDR Report Key11054671
MDR Text Key223161799
Report Number1641965-2020-00024
Device Sequence Number1
Product Code NEP
UDI-Device Identifier04046955048502
UDI-Public04046955048502
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAX1000
Device Catalogue NumberAX1000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/10/2020
Initial Date FDA Received12/22/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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