MAUDE Adverse Event Report: CAREFUSION ALARIS PCA MODULE EXT SET; ALARIS MICROBORE SET

Model Number	30853
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: sr.Sourcing and no product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified patient demographics requested however not provided.Concomitant medical products: 8015; 8110 (4) syringe tube; syringe.
Event or Problem Description
It was reported that the pca ext tubing leaked multiple times.The customer confirmed that there was no patient harm.The event occurred on bmt.A note attached to bag that stated; "leaking, changed multiple time, new tubing lot obtained from another unit , infusing fine".
Additional Manufacturer Narrative
Supplemental created to remove "30853" from d4/serial # because it is a model #.
Event or Problem Description
It was reported that the (pca ext) tubing leaked multiple times.The customer confirmed that there was no patient harm.The event occurred in the bmt.( a note attached to bag that stated; "leaking, changed multiple time, new tubing lot obtained from another unit, infusing fine".).

• Brand Name: ALARIS PCA MODULE EXT SET
• Common Device Name: ALARIS MICROBORE SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9359311
• Report Number: 9616066-2019-03343
• Device Sequence Number: 2790007
• Product Code: FPA
• UDI-Device Identifier: 10885403273995
• UDI-Public: 10885403273995
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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): 10/30/2019

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 Model Number: 30853
• Device Catalogue Number: 30853
• 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: 11/21/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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: ALCOHOL CAPS,THERAPY DATE (B)(6) 2019.