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

Model Number	70003BE-07T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
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 chemo medication daratumumab leaked from an unidentified location on the tubing during an infusion to a patient.There was no harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing leaked from an unidentified location was confirmed.Visual inspection of the set noted clear liquid was inside the 0.2 micron adult filter and tubing throughout the set.No anomalies or evidence of damage were observed.Functional testing resulted in no leaking.Pressure testing confirmed small droplets leaking from the 0.2 micron adult filter¿s bottom air vent (termed ¿weeping out¿).The root cause of the leak was not identified.
Event or Problem Description
It was reported that the chemo medication daratumumab leaked from an unidentified location on the tubing during an infusion to a patient.There was no harm.

• 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: 8845913
• Report Number: 9616066-2019-02094
• Device Sequence Number: 2716468
• Product Code: FPA
• UDI-Device Identifier: 10885403278358
• UDI-Public: 10885403278358
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 70003BE-07T
• Device Catalogue Number: 70003BE-07T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2019
• 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