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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 Problem Fluid Leak (1250)
Patient Problems Dehydration (1807); Nausea (1970); Loss of consciousness (2418)
Event Date 01/02/2021
Event Type  malfunction  
Manufacturer Narrative
Infutronix is waiting for the device to be returned for evaluation.
 
Event Description
On 01/05/2021, a distributor of infutronix reported an issue on behalf of an end user: "white powder at the connection site of the pump to picc line and also on his arm. Daughter called to say that her father fainted yesterday and was taken to the ed by squad. Patient received iv fluids due to dehydration and that medical personnel mentioned he may be having reaction to chemotherapy. Patient is now home. Taking po fluids but feels like he is going to vomit. Advised to call oncologists and talk to physician on call. Daughter asked about giving ondansetron again - ordered every 8 hours. Advised to take ondansetron as prescribed. Reviewed how to call physician on call. Advised to tell physician on call what she has shared. If the physician wanted to nimbus pump to be turned off, to call back and i will assist in turning off pump. " on 01/06/2021, the distributor of infutronix reported additional infomation on behalf of an end user: "patient reported when he got up this morning there was white powder at the connection site of the pump to picc line and also on his arm, medication infused was 5fu. " device operator was a patient. A patient was involved but not harmed. The contract manufacturer of the 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 01760
Manufacturer (Section G)
INFUTRONIX LLC
177 pine street
natick MA 01760
Manufacturer Contact
chaoyoung lee
177 pine street
natick, MA 01760
MDR Report Key11225905
MDR Text Key229361306
Report Number3011581906-2021-00001
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2021
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

Patient Treatment Data
Date Received: 01/25/2021 Patient Sequence Number: 1
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