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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION NEEDLE FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION NEEDLE FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2000E7D
Device Problem Fluid Leak (1250)
Patient Problems Hypoxia (1918); Low Oxygen Saturation (2477)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative
The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
It was reported that on the third day in the icu after a liver transplant, the patient's oxygen saturation dropped suddenly. The doctor then noticed a leakage of blood from the standalone smartsite on one of the 3 lumen of the cvp line; the other two lumen were closed. The blood was consistently flowing from the hub of the valve, and due to the leakage, the patient became hypoxic and required intubation. The preliminary investigation report did not identify any leaking or abnormalities with the set. Although requested, no further information was given by the customer.
 
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Brand NameNEEDLE FREE VALVE
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 Key8428673
MDR Text Key139073565
Report Number9616066-2019-00704
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2000E7D
Device Catalogue Number2000E7D
Device Lot Number16116774
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/18/2019 Patient Sequence Number: 1
Treatment
TRIPLE LUMEN CVP CATHETER, THERAPY DATE: (B)(6) 2019
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