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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION EXTENSION SET SET,EXTENSSION,INTRAVASCULAR

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CAREFUSION EXTENSION SET SET,EXTENSSION,INTRAVASCULAR Back to Search Results
Model Number C20025
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: optia apheresis device; vortex implantable port; apheresis tubing set; large bore needle. (b)(4). The customer report that the extension tubing set pulled air was not confirmed. Visual inspection of the set showed dried blood residue around the area of the luer exit and specks of dried blood residue on both luer caps. Functional testing showed no anomalies. The root cause of the customer's report was not identified. The mating components used during the reported event were not received for investigation.
 
Event Description
The customer reported that they work in conjunction with the american red cross - western blood services division in providing apheresis therapy to their patients and that they are currently in the process of certifying their own apheresis unit. The customer reported that the optia device that performs apheresis treatment alarmed for "air detected in centrifuge" while using the extension tubing set. It was found that the extension tubing set pulled air from the outside into the apheresis kit and caused the kit/plasma exchange to malfunction leaving the nurse with the option of either performing a rinseback or discontinuing the apheresis therapy. Instead, the nurse replaced the extension tubing set to a different product and the issue was resolved. There was no patient harm.
 
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Brand NameEXTENSION SET
Type of DeviceSET,EXTENSSION,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 Key8387743
MDR Text Key139317957
Report Number9616066-2019-00486
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
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 02/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/07/2021
Device Model NumberC20025
Device Catalogue NumberC20025
Device Lot Number18125449
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/07/2018
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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