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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-008-B
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2021, the complaint handling specialist of infutronix confirmed with the customer (not a direct customer) that the affected device was discarded and therefore no root cause could be established.The reported issue was not confirmed.
 
Event Description
On (b)(6) 2021, a complaint handling specialist of infutronix reported an issue on behalf of an end user: "an administration set model hs-008-b lot 2007003 came apart at the 0.2 micron baby filter." device operator was a patient.Medication infused was 5fu.A patient was involved but not harmed.The contract manufacturer of the affected device is podo xingda (b)(4) medical co.Ltd.
 
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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 Key12268899
MDR Text Key264975333
Report Number3011581906-2021-00053
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 other
Type of Report Initial
Report Date 08/02/2021
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 Date08/02/2023
Device Model NumberHS-008-B
Device Lot Number2007003
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/13/2021
Initial Date FDA Received08/03/2021
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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