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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2420-0007
Device Problems Fluid Leak (1250); Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2019
Event Type  malfunction  
Manufacturer Narrative
Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned. The root cause of this failure could not be identified. Patient information was requested, but not provided.
 
Event Description
It was reported that while infusing a chemotherapy mixture of (etopiside, doxorubicin, and vincristine) infusion which had been started early in the am. The customer reported that by 3 pm to 4 pm the soft part of the tubing that is inside the pump developed a bubble (like a aneurysm on the tubing). It was large enough that it forced the door of the infusion pump to open. The bubble did burst and leaked. The nurse clamped the tubing to prevent further leakage. Although, it was reported that patient care was delayed for 2 hours it did not contribute to, or result in serious adverse impact to patient or the caregiver.
 
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Brand NameALARIS® PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, 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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9310095
MDR Text Key190507516
Report Number9616066-2019-03234
Device Sequence Number1
Product Code FPA
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/17/2020
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number17106704
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/17/2017
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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