MAUDE Adverse Event Report: CAREFUSION ALARIS PCA MICROBORE SET; SET, EXTENSION, INTRAVASCULAR

Model Number	30853
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 0ml bd syringe, lot: 9142911, exp: 2022-05-31, 0.9% sodium chloride injection.The customer's report that the primary flush tubing set leaked from the side of the back check valve was not confirmed.During investigation, a crack and resulting leak was observed on the female luer of model 30853.Visual inspection found a crack in the pca female luer wall (p/n 630-01363) on the opposite end of the injection gate of the suspect filter extension set.The location of the luer gate on the female luer (below the ¿wings¿) indicates that this female luer was manufactured after the change order that moved the injection gate to a lower location to help mitigate and prevent female luer cracks.No tool marks or signs of over torque were observed.No issues were observed on the check valve or on any other part of the primary set.Functional testing confirmed the leak in the same location.The customer's report that the primary flush tubing set leaked from the side of the back check valve was not confirmed.The root cause was not identified.However, during the investigation , a crack and resulting leak was observed on the female luer of model 30853.The root cause of the crack was a result of internal stresses created in the luer during the manufacturing process that make it more susceptible to chemical/mechanical attacks.
Event or Problem Description
It was reported that the primary flush tubing set leaked from the side of the back check valve when the pca infusion set was attached to the primary flush.The customer further stated that there were no adverse effects caused to the patient from the event.

• Brand Name: ALARIS PCA MICROBORE SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9220209
• Report Number: 9616066-2019-02967
• Device Sequence Number: 16670838
• Product Code: FPA
• UDI-Device Identifier: 10885403273995
• UDI-Public: 10885403273995
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/30/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR