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

Model Number	10933805
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned.The customer¿s complaint could not be confirmed because the product will not be returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that in the clinical research center, 25 minutes into an infusion, a patient heard a crack when maneuvering out of bed.Upon assessment, it was noted that an engagement of a y-site was broken.Chemotherapy was immediately stopped on the pump module, spill precautions were carried out, the patient was instructed to wash their hands with soap and water, the patient was moved to another room, and the room the spill occurred in the was cleaned.The customer further clarifies that no clothing was soiled during this event.New orders were placed to the patient to receive the remainder of their dose.The customer reported the severity of this event as "mild".There's no report of patient harm.
Event or Problem Description
The customer reported that in the clinical research center, 25 minutes into an infusion, a patient heard a crack when maneuvering out of bed.Upon assessment, it was noted that an engagement of a y-site was broken.Chemotherapy was immediately stopped on the pump module, spill precautions were carried out, the patient was instructed to wash their hands with soap and water, the patient was moved to another room, and the room the spill occurred in the was cleaned.The customer further clarifies that no clothing was soiled during this event.New orders were placed to the patient to receive the remainder of their dose.The customer reported the severity of this event as "mild".There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s complaint of a smartsite y-site was crack was confirmed from a customer provided photo.The customer¿s photo was evaluated and the reported event of crack y-site was observed to be from the body of the smartsite.The root cause of this failure was not identified.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8187204
• Report Number: 9616066-2018-02585
• Device Sequence Number: 19308469
• Product Code: FPA
• UDI-Device Identifier: 07613203019088
• UDI-Public: 7613203019088
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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: 10933805
• Device Catalogue Number: 10933805
• 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: 12/20/2018
• Supplement Report FDA Received Date: 02/01/2019
• 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, THERAPY DATE: (B)(6) 2018
• Patient Age: 53 YR
• Patient Weight: 90