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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFUTRONIX, LLC ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP; IV ADMINISTRATION SET
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INFUTRONIX, LLC ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP; IV ADMINISTRATION SET Back to Search Results
Catalog Number HS-008
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2024
Event Type  malfunction  
Event Description
On 04/02/2024, infutronix received a report that an iv administration set had a "tubing issue - other issue / unknown issue: no longer deliver infusion medications ".The infusion cannot resume without causing delay in treatment.No patient harmed.
 
Manufacturer Narrative
No investigation of the device can be carried out because the iv administration set will not likely be returned for evaluation.
 
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Brand Name
ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP
Type of Device
IV ADMINISTRATION SET
Manufacturer (Section D)
INFUTRONIX, LLC
177 pine street
natick MA 01760
Manufacturer (Section G)
INFUTRONIX, LLC
177 pine street
natick MA 01760
Manufacturer Contact
frederick lee
177 pine street
natick, MA 
MDR Report Key19131139
MDR Text Key341413619
Report Number3011581906-2024-00448
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/17/2024
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 Other
Device Catalogue NumberHS-008
Device Lot Number2004016
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/18/2024
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 Unknown
Patient Sequence Number1
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