MAUDE Adverse Event Report: CAREFUSION ALARIS SECONDARY SET; SET ADMINISTRATION INTRAVASCULAR

Model Number	MS3500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Therapeutic Response, Decreased (2271); Inadequate Pain Relief (2388)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Although requested, patient demographics were not provided.
Event or Problem Description
It was reported that during an infusion of versed to a patient in the nicu, it was noted that leaking was observed at the point where the tubing set was connected to a needleless connector.A minor affect was reported to have occurred since the patient was not receiving a reliable infusion of the sedation medication.The patient was on extracorporeal membrane oxygenation (ecmo) therapy and was having blood pressure and intracranial pressure fluctuations.No additional information was provided.

• Brand Name: ALARIS SECONDARY SET
• Common Device Name: SET ADMINISTRATION INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8527892
• Report Number: 9616066-2019-01013
• Device Sequence Number: 16635622
• Product Code: FPA
• UDI-Device Identifier: 10885403222603
• UDI-Public: 10885403222603
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MS3500
• Device Catalogue Number: MS3500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2019
• 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: B3300/ B1434 ,THERAPY DATE 01/01/2019
• Outcome Attributed to Adverse Event: Other