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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFUTRONIX, LLC ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP; IV ADMINISTRATION SET
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INFUTRONIX, LLC ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP; IV ADMINISTRATION SET Back to Search Results
Model Number HS-004
Device Problems Connection Problem (2900); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/12/2021
Event Type  malfunction  
Manufacturer Narrative
A service provider of infutronix provided the evaluation report for the affected administration set on (b(6) 2021 and visual inspection confirmed that the distal end of the cassette module was completely separated from the cassette.5fu residue was visible inside the tubing.The reported issue was confirmed.
 
Event Description
On (b(6) 2021, infutronix received a complaint from an end user: "an administration set model hs-004 lot 2008003 set came apart at the distal end of the cassette." device operator was a patient.Medication infused was 5fu.A patient was involved but not harmed.The contract manufacturer of the affected device is (b(4).
 
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Brand Name
ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
Type of Device
IV ADMINISTRATION SET
Manufacturer (Section D)
INFUTRONIX, LLC
177 pine street
natick MA 01760
MDR Report Key12523851
MDR Text Key281870295
Report Number3011581906-2021-00073
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00817170020031
UDI-Public00817170020031
Combination Product (y/n)N
PMA/PMN Number
K153193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 09/23/2021
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 Lay User/Patient
Device Expiration Date08/24/2023
Device Model NumberHS-004
Device Catalogue NumberHS-004
Device Lot Number2008003
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/13/2021
Initial Date FDA Received09/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2020
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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