MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP NON VENTED BAG ACCESS SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10013361T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.No investigation was performed.
Event or Problem Description
It was reported that the rn adjusted the blue plastic piece above the door of the channel, when the tubing broke and chemo started spilling.There was no harm to patient.
Additional Manufacturer Narrative
Created to update event description.
Event or Problem Description
It was reported that during an infusion, cytarabine 220 mg iv in 100 ml was circle primed with texium tubing and inserted into the alaris pump after attaching to patient.Rn adjusted the blue plastic piece above the door channel, when the tubing broke and chemo started spilling.Rn was able to contain spill by clamping red clamp on extension tubing (located between pharmacy facile and cytrarbine bag).During this process, chemo was splashed, rn was fully gowned up with chemo gown, double gloved with chemo gloves, had m95 mask and goggles on, however; a drop of chemo landed on rn's right neck.Rn cleaned up the chemo immediately and following clean of spill, washed neck with soap and water.Chemo was recorded and scheduled to start at 11:00pm instead of 10:00pm start time.There was no harm to patient.

• Brand Name: ALARIS PUMP NON VENTED BAG ACCESS SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9241836
• Report Number: 9616066-2019-03039
• Device Sequence Number: 18868356
• Product Code: FPA
• UDI-Device Identifier: 10885403223204
• UDI-Public: 10885403223204
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K053049
• 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): 10/03/2019

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: 10013361T
• Device Catalogue Number: 10013361T
• 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: 10/25/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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