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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 Failure to Align (2522)
Patient Problem No Patient Involvement (2645)
Event Date 07/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device logs have been returned for evaluation.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 multiple occlusions were occurring on port 1.Upon inspection of the transfer set it was noticed that valves 1, 2, 24 and 26 were skewed.No patient involvement.The user replaced the transfer set with no further issues.
 
Event Description
As per user facility: customer reported multiple occlusions were occurring on port 1.Upon inspection of the transfer set it was noticed that valves 1, 2, 24 and 26 were skewed.No patient involvement.The user replaced the transfer set with no further issues.
 
Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).A review of the logs confirmed the user experienced 4-6 occlusions on macro 1 before opening the sensor door, opening the platens and eventually switching sets.Given that a transfer set of the same lot then performed without issue, the first set was likely not installed fully.Without extra occlusion information provided in software rev k, it is impossible to know why the occlusion alerts were occurring.One (1) used set, with packaging, was returned for evaluation.Visual examination of the set noted no visual defects.The set was occlusion tested on all of the lines with emphasis on lines 1, 2, 24, and 26 with passing results.Visual examination of a retained transfer set noted no visual defects.The retained unit was occlusion tested with passing results.Review of the discrepancy management system (dsms) database performed for the reported transfer set lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.Based on the results of the investigation this complaint is not confirmed for valve misalignment.B.Braun will continue to investigate, trend, and monitor all complaints of this nature.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 Key7722483
MDR Text Key115126962
Report Number1641965-2018-00017
Device Sequence Number1
Product Code NEP
UDI-Device Identifier04046955048502
UDI-Public(01)04046955048502
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 09/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2018
Date Manufacturer Received07/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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