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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
Catalog Number 601224
Device Problem Application Program Problem: Dose Calculation Error (1189)
Patient Problem No Patient Involvement (2645)
Event Date 02/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device logs have been received.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
 
Event Description
As per user facility: customer reported a concern on the volumes of total parental nutrition (tpn).It was reported the actual ordered volume for the bag was 1560 ml with no negative water.The total delivered volume on the compounding activity report (car) is showing as 1723.33 ml.The ordered volume on the car is showing as 1960 ml (no vial change with different ndc occurred for this bag).The main issue appears to be sterile water lines on car.One line shows the correct ordered volume of 103.33 ml and another line shows incorrect ordered volume of 400 ml.They both show incorrect dispensed volume of 163.33 ml.The bag was rejected even though it passed the variance.No patient involvement.
 
Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device logs were reviewed.The software issue has to do with scanning the source line barcode from the main screen to bring up the "replace container" screen for the current universal ingredient.When this is done in the middle of an order (only possible if user first presses "pause"), then the universal ingredient will revert from whatever station it was (2 or 3) to station 1.The final flush of the order will be performed with sterile water from station 1 instead of the intended universal ingredient.This will result in less volume of the intended universal ingredient in the amount of the flush volume and more of station 1 (water) than intended in the amount of the flush volume.Some of this flush volume will not make it into the final container, as it will be used to fill the manifold for the next order.Also, a manifold flush will be required prior to that next order.Additionally, the compounding activity report will show incorrect values for both delivered volume and ordered volume, neither will reflect the intended ordered volume.This issue is to be addressed in the next release of apex software.If additional pertinent information becomes available a follow-up report will be filed.
 
Event Description
As per user facility: customer reported a concern on the volumes of total parental nutrition (tpn).It was reported the actual ordered volume for the bag was 1560 ml with no negative water.The total delivered volume on the compounding activity report (car) is showing as 1723.33 ml.The ordered volume on the car is showing as 1960 ml (no vial change with different ndc occurred for this bag).The main issue appears to be sterile water lines on car.One line shows the correct ordered volume of 103.33 ml and another line shows incorrect ordered volume of 400 ml.They both show incorrect dispensed volume of 163.33 ml.The bag was rejected even though it passed the variance.No patient involvement.
 
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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 Key8413113
MDR Text Key138555767
Report Number1641965-2019-00006
Device Sequence Number1
Product Code NEP
UDI-Device Identifier4046964801068
UDI-Public(01)4046964801068
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 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number601224
Was Device Available for Evaluation? No
Date Manufacturer Received02/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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