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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET
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CAREFUSION NON-VENTED BLOOD SET Back to Search Results
Model Number 2478-0000
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
 
Event or Problem Description
The customer reported that shortly after the start of a platelet transfusion, the platelet line leaked at the entrance to the long filter chamber.The set was primed with normal saline on one spike, iv patency confirmed, and the infusion was started.The nurse then spiked the platelet bag and started to prime that tubing segment leading to the filter chamber.The leak was observed at the top of the chamber.No patient harm was reported.
 
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Brand Name
NON-VENTED BLOOD SET
Common Device Name
BLOOD SET
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8042956
Report Number9616066-2018-02123
Device Sequence Number1463800
Product Code FPA
UDI-Device Identifier10885403235122
UDI-Public10885403235122
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K894842
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 10/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number2478-0000
Device Catalogue Number2478-0000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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