MAUDE Adverse Event Report: CAREFUSION NON-VENTED GRAVITY BLOOD SET

Model Number	42081E
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2018
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 not returned for failure investigation.The root cause of this failure was not identified.(b)(4).
Event or Problem Description
The customer reported that the blood tubing came apart at the spike when administrating blood.Received a copy of the customer's medsun report from the fda which states "the tubing at the spike connection for the carefusion gravity blood tubing came apart." "blood administration during ct surgery".
Additional Manufacturer Narrative
No product will be returned.The customer provided a picture that shows the set leaked and separated at the spike.The root cause was not identified.
Event or Problem Description
The customer reported that the blood tubing leaked and came apart at the spike when administrating blood.Although requested there are no additional details provided at this time.There was no report of patient harm.Received a copy of the customer's medsun report from the fda which states "the tubing at the spike connection for the carefusion gravity blood tubing came apart." "blood administration during ct surgery".

• Brand Name: NON-VENTED GRAVITY BLOOD SET
• Common Device Name: BLOOD SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7887799
• Report Number: 9616066-2018-01713
• Device Sequence Number: 19348153
• Product Code: FPA
• UDI-Device Identifier: 07613203020855
• UDI-Public: 7613203020855
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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 Number: 42081E
• Device Catalogue Number: 42081E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1