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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
Catalog Number 490100
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2024
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: detailed inquiry description: running secondary set.2 micron filter found it was leaking where it connects to the primary tubing.Air noticed down the line pump didn't alarm.No injury reported.
 
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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 18109
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 18109
4847197287
MDR Report Key18884419
MDR Text Key337441373
Report Number2523676-2024-00262
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142036
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/12/2024
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 Catalogue Number490100
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/01/2024
Initial Date FDA Received03/12/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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