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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALARIS PUMP MODULE SMARTSITE INFUSION SET PUMP INFUSION SET

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ALARIS PUMP MODULE SMARTSITE INFUSION SET PUMP INFUSION SET Back to Search Results
Model Number 2426-0007
Device Problems Complete Blockage (1094); Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone number: (b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that alaris pump module smartsite infusion set was clogged. The following information was provided by the initial reporter: "it was reported by the customer that the iv ports were jammed. ".
 
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Brand NameALARIS PUMP MODULE SMARTSITE INFUSION SET
Type of DevicePUMP INFUSION SET
MDR Report Key12455173
MDR Text Key270919061
Report Number9616066-2021-52013
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 10/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot Number21026103
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2021
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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