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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT; SET, ADMINISTRATION, INTRA
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B. BRAUN MEDICAL INC. INFUSOMAT; SET, ADMINISTRATION, INTRA Back to Search Results
Model Number 363410
Device Problem Fluid/Blood Leak (1250)
Patient Problem Tachycardia (2095)
Event Date 01/24/2020
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b.Braun medical 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 reported by the user facility: it was reported that while amino acids were running in picc line, the filter leaked slightly.Tachycardia noted.
 
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No samples or photos were provided for evaluation.Without the actual device and/or lot number, a thorough investigation could not be performed and a root cause could not be established.The batch record and our discrepancy management system database could not be reviewed as a lot number was not provided.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available a follow-up report will be filed.
 
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Brand Name
INFUSOMAT
Type of Device
SET, ADMINISTRATION, INTRA
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown, pa
MDR Report Key10071874
MDR Text Key191869280
Report Number2523676-2020-00143
Device Sequence Number1
Product Code FPA
UDI-Device Identifier04046964294556
UDI-Public04046964294556
Combination Product (y/n)N
PMA/PMN Number
K142036
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number363410
Device Catalogue Number363410
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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