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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION PUMP MODULE ADMINISTRATION SET; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION PUMP MODULE ADMINISTRATION SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 2420-0500
Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/06/2019
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.No investigation was performed.
 
Event Description
It was reported that the primary line broke mid-infusion at the pump segment resulting in a chemotherapy, (trastuzumab in 250 ml 0.9% nacl), spill which splashed onto the nurse.This event occurred in the outpatient oncology infusion center.There was no harm to the nurse.There was no patient harm.
 
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Brand Name
PUMP MODULE ADMINISTRATION SET
Type of Device
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8451785
MDR Text Key139840637
Report Number9616066-2019-00768
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012430
UDI-Public7613203012430
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/17/2021
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot Number18123092
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/26/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
8015,8100, THERAPY DATE 01/01/2019
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