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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION GRAVITY SET SET,ADMINISTRATION,INTRAVASCULAR

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CAREFUSION GRAVITY SET SET,ADMINISTRATION,INTRAVASCULAR Back to Search Results
Model Number 10010903
Device Problems Insufficient Flow or Under Infusion (2182); Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/22/2019
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. Although requested, patient demographics not provided.
 
Event Description
The customer reported that the spike tubing union kinked when trying to prime the set. They hold the priming fluid upside down to purge the air out the top. In doing so, the spike was upside down too for the purge and it kinked at the tubing spike union. There was a 10-20 minute delay in treatment of massive blood loss. There was no harm.
 
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Brand NameGRAVITY 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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8401869
MDR Text Key138279409
Report Number9616066-2019-00697
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203020879
UDI-Public7613203020879
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K882302
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10010903
Device Catalogue Number10010903
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
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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