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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-001
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2021
Event Type  malfunction  
Manufacturer Narrative
Infutronix is waiting for the device to be returned for evaluation.
 
Event Description
On (b)(6) 2021, a distributor of infutronix reported an issue on behalf of an end user: "the tubing was separated.In the photo, it was clear that the tubing was somehow cut and the patient also made a comment that her cat might have bit it off." device operator was a patient.Medication infused was unknown.A patient was involved but not harmed.The contract manufacturer of the affected device is (b)(6) medical co.Ltd.
 
Manufacturer Narrative
On 07/02/2021, infutronix confirmed with the service provider that the affected device was never returned and therefore no root cause could be established.The reported issue was not confirmed.
 
Event Description
This is a follow-up for the initially filed mdr 3011581906-2021-00045.
 
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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 Key12097456
MDR Text Key260108702
Report Number3011581906-2021-00045
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00817170020017
UDI-Public00817170020017
Combination Product (y/n)N
PMA/PMN Number
K153193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberHS-001
Device Catalogue NumberHS-001
Was Device Available for Evaluation? No
Date Manufacturer Received07/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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