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

Model Number	72215N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The reported feedback suggests that there was a leakage of cytotoxic drugs.From the reported information there are no indications of serious injury to the patient or user as a result of cytotoxic exposure.
Additional Manufacturer Narrative
Cont¿d d.11: 1000ml sodium chloride fluid bag; fresenius infusion set; 500ml sodium chloride fluid bag.The customer¿s report of leakage was not confirmed.Visual inspection did not observe any anomalies.Functional and pressure testing was not able to replicate any leakage.The root cause of the reported leakage was not determined.
Event or Problem Description
The reported feedback suggests that there was a leakage of cytotoxic drugs.From the reported information there are no indications of serious injury to the patient or user as a result of cytotoxic exposure.

• Brand Name: ALARIS® SECONDARY ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8793641
• Report Number: 9616066-2019-01961
• Device Sequence Number: 13934530
• Product Code: FPA
• UDI-Device Identifier: 10885403235467
• UDI-Public: 10885403235467
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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 Expiration Date: 02/08/2022
• Device Model Number: 72215N
• Device Catalogue Number: 72215N
• Device Lot Number: 19025496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1