MAUDE Adverse Event Report: CAREFUSION ALARIS PCA MODULE SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10800173
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that the connection by the check value cracked and leaked during use in the icu.There was delay in treatment due to changing out of the iv tubing set to a new one.There was no patient impact.
Event or Problem Description
It was reported that the connection by the check value cracked and leaked during use in the icu.There was delay in treatment due to changing out of the iv tubing set to a new one.Although it was noted that there was a delay in treatment, it was also confirmed during follow up, that there was no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
Additional information added; section; b.5.(patient information clarified/detailed).The customer¿s report of that the connection by the check value cracked and leaked was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted a crack in the female luer wall on the opposite end of the injection gate of the set.The location of the luer gate on the female luer (below the ¿wings¿) indicates that this female luer was manufactured 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 damages were observed on the male luer.Functional testing confirmed leaking from the cracked female luer.The source of the leak is due to a crack in the female luer component.The root cause of the crack is a result of internal stresses created in the luer during the manufacturing process that make it more susceptible to chemical/mechanical attacks.
Additional Manufacturer Narrative
Additional information provided: d.11 although requested, information on a4 and b7 were not provided.
Event or Problem Description
It was reported that the connection by the check valve cracked and leaked during use in the intensive care unit (icu).There was a delay in treatment due to changing out of the iv tubing set to a new one.Although it was noted that there was a delay in treatment, it was also confirmed during follow up, that there was no patient harm or impact as a result of this event.

• Brand Name: ALARIS PCA MODULE SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9759253
• Report Number: 9616066-2020-00549
• Device Sequence Number: 16838764
• Product Code: FPA
• UDI-Device Identifier: 10885403234385
• UDI-Public: 10885403234385
• 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,Followup,Followup
• Report Date (Section B): 02/03/2020

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: 10800173
• Device Catalogue Number: 10800173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/06/2020; 05/07/2020
• 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: 8015,8120,SYRINGE, THERAPY DATE (B)(6) 2020.
• Patient Age: 16 YR