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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 Problems Disconnection (1171); Reflux within Device (1522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2023
Event Type  malfunction  
Manufacturer Narrative
Return of the device has been requested.As of the date of this report, device has not been returned.
 
Event Description
Patient reported their tubing set had become disconnected from the pump.The blood also backed into the tubing.The patient was instructed to turn the pump off, clamp the line and call their clinic first thing in the morning.Medication being infused was unknown.No patient injury reported.
 
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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
chaoyung lee
177 pine street
natick, MA 01760
5086502007
MDR Report Key18088475
MDR Text Key327712146
Report Number3011581906-2023-00205
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
Reporter Occupation Other
Type of Report Initial
Report Date 11/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2023
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 Received10/18/2023
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
Patient Age56 YR
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