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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10013364
Device Problems Infusion or Flow Problem (2964); Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 09/01/2021
Event Type  malfunction  
Event Description
The patient was receiving oxaliplatin (chemotherapy) infusion. The nurse was called by the patient to assist him to use the bathroom. When the nurse arrived at the bedside, another nurse, who had gone to assist the patient prior to the first nurse's arrival, was found to be holding oxaliplatin bag that had been severed from the tubing. The patient did not have any of the oxaliplatin on him, nor did the other rn. The area was cleansed per protocol, primary tubing was replaced with new tubing and patient resumed chemo regimen. Based on volume to be infused remaining on the patients oxaliplatin infusion he lost approximately 10. 5cc of the 300cc oxaliplatin. Doctor was made aware. Nursing director, the oncology clinical nurse specialist, pharmacy, the patient, and patient's sister also notified. Manufacturer response for bd smatsite intravenous set, bd smatsite intravenous set (per site reporter).
 
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Brand NameALARIS, SMARTSITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd.
san diego CA 92121
MDR Report Key12505956
MDR Text Key272471835
Report Number12505956
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
Type of Report Initial
Report Date 09/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10013364
Device Catalogue Number10013364
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/13/2021
Event Location No Information
Date Report to Manufacturer09/21/2021
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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