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	05/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: broviac central line; 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.Additional patient information: infant; race: b.
Event or Problem Description
It was reported that a continuous infusion of fentanyl infusing at a rate of 0.8ml/hour via the infant patients broviac central line located in the patient's right femoral artery when it was noticed that the patients bed linens were wet.Upon assessment, the nurse found that the tubing set was wet.The tubing set was dried only to find it wet again.
Additional Manufacturer Narrative
The customer¿s report of a leak was not confirmed.Visual inspection of the set noted no damage or any anomalies.Functional and pressure testing resulted in the set flowing freely and showed no signs of leaking.The set was loaded into a lab syringe pump module for an infusion test.The primary infusion was programmed at a rate of 0.8ml/h and 0.8 ml vtbi.The infusion completed with no alarms and no signs of leaking.The root cause was not identified.
Event or Problem Description
It was reported that a continuous infusion of fentanyl infusing at a rate of 0.8ml/hour via the infant patients broviac central line located in the patient's right femoral artery when it was noticed that the patients bed linens were wet.Upon assessment, the nurse found that the tubing set was wet.The tubing set was dried only to find it wet again.

• 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: 8786777
• Report Number: 9616066-2019-01904
• Device Sequence Number: 13962663
• 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: 08/21/2019
• 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: 8100,8015, TD (B)(6) 2019
• Patient Age: 4 MO