MAUDE Adverse Event Report: CAREFUSION ALARIS® SYRINGE MODULE SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10014916
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: double lumen picc; syringe, size and mfr.Unknown.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
It was reported that the tubing set leaked during a continuous infusion of dopamine infusing greater than 24 hours at a rate of 0.8-0.9ml/hour via the patient's picc line located in the infant patient's right femoral artery.The dopamine syringe and tubing set was replaced.
Additional Manufacturer Narrative
The customer¿s report of a leak was confirmed.Visual inspection of the set noted a crack in the female luer wall 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.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.
Event or Problem Description
It was reported that the tubing set leaked during a continuous infusion of dopamine infusing greater than 24 hours at a rate of 0.8-0.9ml/hour via the patient's picc line located in the infant patient's right femoral artery.The dopamine syringe and tubing set was replaced.

• Brand Name: ALARIS® SYRINGE MODULE SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8786895
• Report Number: 9616066-2019-01905
• Device Sequence Number: 1668108
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: 10014916
• Device Catalogue Number: 10014916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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: 8110,8015, THERAPY DATE (B)(6) 2019
• Patient Age: 7 MO