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	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
The customer reported that at the start of a blood transfusion on a pump, blood began to leak around the iv pump door.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of a leak ¿around the iv pump door¿ was confirmed, in that a small tear was discovered at the top end of the silicone pump segment.Due to the amount of blood product remaining in the tubing set overall, functional testing was not performed, and the reported leak was not reproduced.Examination under magnification revealed a small, rough-edged tear in the tubing, just below the upper retainer ring.Both retainer rings were in place and intact, and neither the upper nor lower fitment showed evidence of damage.The root cause could not be determined.
Event or Problem Description
The customer reported that at the start of a blood transfusion on a pump in the emergency department, blood began to leak around the iv pump door.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: 7856560
• Report Number: 9616066-2018-01603
• Device Sequence Number: 11278228
• Product Code: FPA
• UDI-Device Identifier: 10885403235122
• UDI-Public: 10885403235122
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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: 05/30/2021
• Device Model Number: 2478-0000
• Device Catalogue Number: 2478-0000
• Device Lot Number: 18055461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1