MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET

Model Number	2478-0000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
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 the patient was to receive one unit of prbc and that shortly after the initiation of the transfusion, the blood began to bubble out of the top of the drip chamber.There was no report of patient harm.
Event or Problem Description
The customer reported that the patient was to receive one unit of prbc and that shortly after the initiation of the transfusion, the blood began to bubble out of the top of the drip chamber.There was no patient harm.
Event or Problem Description
The customer reported that the patient was to receive one unit of prbc and that shortly after the initiation of the transfusion, the blood began to bubble out of the top of the drip chamber.There was no report of patient harm.
Additional Manufacturer Narrative
The picture provided by the customer shows that the pvc tubing was leaking blood from the drip chamber blood filter top cap, confirming the report.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that the patient was to receive one unit of prbc and that shortly after the initiation of the transfusion, the blood began to bubble out of the top of the drip chamber.There was no patient harm.

• 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 Key: 7851359
• Report Number: 9616066-2018-01587
• Device Sequence Number: 11182282
• Product Code: FPA
• UDI-Device Identifier: 10885403235122
• UDI-Public: 10885403235122
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/16/2018

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 Expiration Date: 12/06/2020
• Device Model Number: 2478-0000
• Device Catalogue Number: 2478-0000
• Device Lot Number: 17125221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 09/11/2018; 09/28/2018; 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015,8100, THERAPY DATE (B)(6) 2018
• Patient Age: 36 YR
• Patient Weight: 100