MAUDE Adverse Event Report: CAREFUSION PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION

Model Number	2278-0500
Medical Device Problem Codes	Emergency Power Failure (1205); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Although requested, patient demographics not provided.
Event or Problem Description
It was reported that tubing was leaking below the upper blue fitment / silicone segment.
Additional Manufacturer Narrative
Leukemia - currently receiving active treatment for cancer diagnosis.The customer¿s report that the tubing leaked below the upper blue fitment/silicone segment was not confirmed.Received from the customer unopened sets model 2278-0500 lot 18085042; customer did not send in the suspect blood filter set this event took place on.Functional testing was performed, the set flowed slowly and showed no signs of leaking at the silicone segment, upper fitment or anywhere else throughout the sets.The root cause could not be identified.No device received- associate products received.
Event or Problem Description
It was reported that while priming an infusion set with blood, the tubing leaked below the upper blue fitment / silicone segment.

• Brand Name: PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8491757
• Report Number: 9616066-2019-00922
• Device Sequence Number: 13781794
• Product Code: FPA
• UDI-Device Identifier: 10885403223266
• UDI-Public: 10885403223266
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

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: 07/31/2021
• Device Model Number: 2278-0500
• Device Catalogue Number: 2278-0500
• Device Lot Number: 18085042
• 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: 04/08/2019
• Supplement Report FDA Received Date: 06/04/2019
• 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: 3 ASSOCIATES 2278-0500, TD (B)(6) 2019; 3 ASSOCIATES 2278-0500, TD (B)(6) 2019
• Patient Age: 3 YR
• Patient Weight: 12