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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
Catalog Number HS-008
Device Problem Break (1069)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2021, infutronix received an image of the administration set with the attachment.Visual inspection confirmed that the attachment is broken, which was caused by patient stepped on the device.
 
Event Description
On (b)(6) 2021, infutronix received a complaint from an end user: "an administration set model hs-008 lot 2006015 the set broke and led to her bleeding.The site saw her in the morning on (b)(6) 2021 and confirmed she stepped on the set and it led to the break.It also appears to be broken at an attachment on the tubing, and not the tubing its self." the attachment was not a product of infutronix.Device operator was a patient.Medication infused was 5fu.A patient was involved and 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 Key12360498
MDR Text Key267904607
Report Number3011581906-2021-00060
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 08/23/2021
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 Date07/05/2023
Device Catalogue NumberHS-008
Device Lot Number2006015
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/02/2021
Initial Date FDA Received08/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age62 YR
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