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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
Catalog Number HS-008-B
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/12/2021
Event Type  malfunction  
Event Description
On (b)(6) 2021, infutronix received a complaint from an end user: "an administration set model hs-008-b lot 2007003 came apart at the filter.She states this happened from the patient incorrectly disconnecting the pump." 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).
 
Manufacturer Narrative
On (b)(6) 2021, infutronix confirmed with the distributor that the affected device was never returned for evaluation and therefore no root cause could be established.The reported issue was not confirmed.
 
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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 Key12412621
MDR Text Key282962953
Report Number3011581906-2021-00064
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K153193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 09/01/2021
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 Lay User/Patient
Device Expiration Date08/02/2023
Device Catalogue NumberHS-008-B
Device Lot Number2007003
Was Device Available for Evaluation? No
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2020
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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