MAUDE Adverse Event Report: CAREFUSION ALARIS SYSTEM W/TEXIUM &BAG ACCESS PORT; SET, ADMINISTRATION, INFUSION

Model Number	22000-B007T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
Event or Problem Description
It was reported that the chemotherapy medication, gemzar, leaked from the texium tubing while connected to a patient.Although requested, there were no further details or information provided and no report of harm.
Event or Problem Description
It was reported that the chemotherapy medication, gemzar, leaked from the texium tubing while connected to a patient.There was no harm.
Additional Manufacturer Narrative
No product will be returned per customer.No investigation was performed.The customer complaint of texium tubing leaking could not be confirmed due to the product was not returned for failure investigation.The root cause was not identified as no product was returned.

• Brand Name: ALARIS SYSTEM W/TEXIUM &BAG ACCESS PORT
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8601444
• Report Number: 9616066-2019-01338
• Device Sequence Number: 16717607
• Product Code: FPA
• UDI-Device Identifier: 10885403245022
• UDI-Public: 10885403245022
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2019

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: 22000-B007T
• Device Catalogue Number: 22000-B007T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 100