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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
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2022
Event Type  malfunction  
Manufacturer Narrative
Infutronix is waiting for the affected device to be returned.
 
Event Description
A distributor of infutronix received a complaint from the spouse of a patient, reporting pump was leaking.The area of the leak was where the clear tubing screws into the yellow connector.Patient's spouse was instructed to power down the pump, clamp the tubing, and call and speak to the anesthesia doctor to find out how to proceed and to provide alternative pain management if necessary.Device operator was the patient.Medication being infused was unknown.No patient injury reported.The contract manufacturer of the affected device is podo xingda (tianjin) 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
Manufacturer (Section G)
INFUTRONIX, LLC.
177 pine street
natick MA 01760
Manufacturer Contact
chaoyoung lee
177 pine street
natick, MA 01760
5086502007
MDR Report Key15855304
MDR Text Key305901107
Report Number3011581906-2022-00227
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 Other,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received11/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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