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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
Device Problems Failure to Prime (1492); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2021
Event Type  malfunction  
Manufacturer Narrative
On 08/24/2021, infutronix confirmed with the end user that the affected device was never returned for evaluation and therefore no root cause could be established.The reported issue was not confirmed.
 
Event Description
On 08/06/2021, infutronix received a complaint from an end user: "an administration set model hs-008 lot 2006015 air started to fill the bag from the set even though the set was closed off." device operator was a registered nurse.Medication infused was unknown.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 Key12376829
MDR Text Key268445998
Report Number3011581906-2021-00063
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 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/05/2023
Device Catalogue NumberHS-008
Device Lot Number2006015
Was Device Available for Evaluation? No
Date Manufacturer Received08/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2020
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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