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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-002
Device Problems Break (1069); Fluid Leak (1250); Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2020
Event Type  malfunction  
Manufacturer Narrative
Infutronix is waiting for the device to be returned for evaluation.
 
Event Description
On (b)(6) 2020, a distributor of infutronix reported the following on behalf of a patient end user : "patient reported the bag being very wet and couldn't tell where the leaking was coming from. After drying the medication and pump, she saw the administration set snapped at the side and broke. " device operator was a patient. A patient was involved but not harmed. The contract manufacturer of the affected device is (b)(4).
 
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Brand NameADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
Type of DeviceIV ADMINISTRATION SET
Manufacturer (Section D)
INFUTRONIX, LLC
177 pine street
natick, ma
Manufacturer (Section G)
INFUTRONIX LLC
177 pine street
natick, ma
Manufacturer Contact
chaoyoung lee
177 pine street
natick, ma 
3158201
MDR Report Key10488429
MDR Text Key206382702
Report Number3011581906-2020-00023
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 distributor,other,user facili
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHS-002
Device Catalogue NumberHS-002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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