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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 24301-0007T
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer. The customer complaint could not be confirmed because the product was not returned for failure investigation. The root cause of this failure was not identified.
 
Event Description
The customer reported that during unspecified chemotherapy infusions, the staff noticed medication remaining in the line after the completion of the infusions. The nurses are having to finish administering the remaining medication by use of gravity. It was reported that when using both the non-filtered and the filtered sets during the gravity process, blood from the patient returns into the line after the set has been in use for 15 minutes or up to two hrs. "the clinicians are requesting to have a valve on the lines so the patients¿ blood is not coming into the line and they are able to administer all of the medication during treatments". The events ¿occurred on multiple occasions starting around the beginning of december¿. There was no report of patient harm. The events are occurring in the cancer infusion center.
 
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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 Key8207058
MDR Text Key131770033
Report Number9616066-2018-02602
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/02/2021
Device Model Number24301-0007T
Device Catalogue Number24301-0007T
Device Lot Number18115033
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 Manufactured11/02/2018
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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