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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET

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ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET Back to Search Results
Catalog Number HS-008
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  malfunction  
Event Description
On (b)(6) 2021, infutronix received a complaint from an end user: "an administration set model hs-008 lot 2008005 set was leaking somewhere near the pump. " device operator was a patient. Medication infused was 5fu. A patient was involved but not harmed. (b)(4).
 
Manufacturer Narrative
On 09/24/2021, infutronix confirmed with the service provider that the affected device was never returned for evaluation and the image from the customer cannot confirm the reported issue. Therefore no root cause could be established. The reported issue was not confirmed.
 
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Brand NameADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP
Type of DeviceIV ADMINISTRATION SET
MDR Report Key12625251
MDR Text Key281675207
Report Number3011581906-2021-00072
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 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberHS-008
Device Lot Number2008005
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2020
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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