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

Model Number	10015489
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
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.Patient demographics requested however not provided.
Event or Problem Description
It was reported that during an azacitidine (200 mg) infusion at an unspecified rate, the device alarmed.Upon further examination, the set separated and leaked at the male luer.It was reported that the chemo leak did not reach the patient skin.There was no indication of patient harm.
Event or Problem Description
It was reported that during an azacitidine (200 mg) infusion at an unspecified rate, the device alarmed.Upon further examination the set separated and leaked at the male luer.It was reported that the chemo leak did not reach the patient skin.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of tubing separated at male luer and leaked was confirmed.Visual inspection of the set noted that vinyl tubing was completely separated from the distal male luer.Examination under magnification noted that both sides of the vinyl tubing had insufficient solvent applied at the engagement.There were no other anomalies observed.Functional testing was deemed unnecessary due to separation.Dimensional analysis was performed and the vinyl tubing measured to be within specification.The cause of the leak was due to the tubing separating at the tubing engagement.The root cause of the separation was identified as a manufacturing issue due to insufficient solvent being applied at the junction of the vinyl tubing.

• 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: 8448367
• Report Number: 9616066-2019-00810
• Device Sequence Number: 429584
• Product Code: FPA
• UDI-Device Identifier: 07613203021050
• UDI-Public: 7613203021050
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 02/27/2019

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 Expiration Date: 10/10/2021
• Device Model Number: 10015489
• Device Catalogue Number: 10015489
• Device Lot Number: 18105808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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) 2019; 8100,8015, THERAPY DATE: (B)(6) 2019