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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 2420-0500
Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer. The customer complaint could not be confirmed because the product was not sequestered for failure investigation. The root cause of this failure was not identified.
 
Event Description
The customer reported that the tubing broke at the male luer spin collar and leaked while infusing a chemotherapeutic medication on more than one occasion. There was no patient harm. Received a copy of the customer's sus voluntary event report from fda, which states ¿veteran reported to nursing desk that he had broken his line. Upon inspection it was determined that patients iv tubing had broken apart at the hub. A chemotherapeutic agent (5fu) was spilled on the floor and bedding. Chemo spill protocol was initiated. Housekeeping used detergent and water rinses to floor and bed. Veteran iv site was assessed for damage, and md and pharmacy notified. Exposure forms were filled out and given to supervisor. I was told from unit staff this has happened many times this is the first event that i have seen with regards to this type. ".
 
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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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7654740
MDR Text Key112872269
Report Number9616066-2018-00946
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 health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 06/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/29/2021
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot Number18015721
Other Device ID Number7613203012430
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/29/2018
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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