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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 11532269
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2020
Event Type  malfunction  
Event Description
The iv tubing was not able to be primed due to faulty manufacturing. First access port (access site directly below pump chamber) is downward instead of necessary upward position. Medication could not be primed past the first access port.
 
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Brand NameALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key10641651
MDR Text Key210230278
Report Number10641651
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11532269
Device Catalogue Number10885403232343
Device Lot Number20056497
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/24/2020
Event Location Outpatient Treatment Facility
Date Report to Manufacturer10/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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