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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFUSOMAT®; SET, ADMINISTRATION, INTRA
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INFUSOMAT®; SET, ADMINISTRATION, INTRA Back to Search Results
Model Number 490105
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 there was air in line during use.No injury reported.
 
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
 
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Brand Name
INFUSOMAT®
Type of Device
SET, ADMINISTRATION, INTRA
MDR Report Key12419056
MDR Text Key269811135
Report Number2523676-2021-00296
Device Sequence Number1
Product Code FPA
UDI-Device Identifier04046964186165
UDI-Public04046964186165
Combination Product (y/n)N
PMA/PMN Number
K142036
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number490105
Device Catalogue Number490105
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/19/2021
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
Patient Sequence Number1
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