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
Continued from report source - (b)(6).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.
Event or Problem Description
It was reported that the pca ext tubing leaked multiple times.The customer confirmed that there was no patient harm.A note attached to bag that stated; "leaking, changed multiple time, new tubing lot obtained from another unit , infusing fine.".
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".).
Additional Manufacturer Narrative
Supplemental to revise b5 and remove lot number, manuf./expir.Dates (d4, h4).The customer¿s report that the pca ext tubing leaked was confirmed on one of the two returned sets.The source of the leak is due to cracks in the female luer component for set model 30853.Visual inspection confirmed that one of the two returned sets¿ female luer had lateral cracks.Closer inspection observed signs of over torque due to the damages on the surface of the female luer.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Functional testing was performed on set 1 by attaching a 10ml lab syringe filled with blue dye water to one of the pca set¿s female luer near the check valve.With the pinch clamp engaged on tubing with the anti-siphon valve, the syringe plunger was very slowly depressed to gently flush out the remaining fluid.The set leaked from the cracked female luer.The syringe was then attached to the anti-siphon valve with the pinch clamps disengaged and was gently flushed.No other leaks were observed throughout the set.The root cause of the cracks were identified to be a result of internal stresses created during the manufacturing process that make it more susceptible to chemical/mechanical attacks and the pvc materials used in the new female luer.

• 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: 9358440
• Report Number: 9616066-2019-03337
• Device Sequence Number: 2093681
• 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 Expiration Date: 06/04/2022
• Device Model Number: 30853
• Device Catalogue Number: 30853
• Device Lot Number: 19065362
• 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: 02/18/2020
• 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: 8015,(4)CAD SYR TUBE; ALCOHOL CAPS,THERAPY DATE (B)(4) 2019.