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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 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.
 
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Brand NameINFUSOMAT
Type of DeviceSET, ADMINISTRATION, INTRA
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown, pa
Manufacturer (Section G)
B. BRAUN DOMINICIAN REPULIC INC.
las americas industrial park
km22 autopista las americas
santo domingo
DR
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, pa 
7197287
MDR Report Key10071874
MDR Text Key191869280
Report Number2523676-2020-00143
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K142036
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
0 Patients were 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
Device Model Number363410
Device Catalogue Number363410
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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