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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFUTRONIX, LLC ADMINISTRATION SET FOR NIMBUS II FLEX; IV ADMINISTRATION SET
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INFUTRONIX, LLC ADMINISTRATION SET FOR NIMBUS II FLEX; IV ADMINISTRATION SET Back to Search Results
Model Number HS-004
Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2018
Event Type  malfunction  
Manufacturer Narrative
Infutronix is waiting for the arrival of the device.
 
Event Description
The initial reporter reported a leaking issue of an administration set to infutronix on (b)(6) 2018."we had an incident today where a patient came in and his entire pump bag had 5fu leakage on it and his pump was actively still leaking." no patient injury or harm was reported for this case.The contract supplier of the affected device is (b)(4).
 
Event Description
This is a follow-up for the initially filed mdr (3011581906-2018-00009).
 
Manufacturer Narrative
The reported leaking issue was confirmed by the distributor.The leakage was observed at the exit site on the cassette.However, due to the contaminated nature of the device, the distributor scrapped the affected administration set and did not return it to infutronix for further investigation.
 
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Brand Name
ADMINISTRATION SET FOR NIMBUS II FLEX
Type of Device
IV ADMINISTRATION SET
Manufacturer (Section D)
INFUTRONIX, LLC
177 pine street
natick MA 01760
MDR Report Key7627036
MDR Text Key112037939
Report Number3011581906-2018-00009
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00817170020031
UDI-Public00817170020031
Combination Product (y/n)N
PMA/PMN Number
K153193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHS-004
Device Catalogue NumberHS-004
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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