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

Model Number	10879047
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
The customer reported that the tubing broke and that a patient care alert/incident/safety report was internally generated to document this event.There was no report of patient harm.
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that the tubing broke with a secondary set y'd into the connection port nearest the patient and that a patient care alert/incident/safety report was internally generated to document this event.There was no report of patient harm.
Event or Problem Description
The customer reported that the tubing broke with a secondary set y'd into the connection port nearest the patient and that a patient care alert/incident/safety report was internally generated to document this event.There was no report of patient harm.The customer reported that when the nurse was removing the iv tubing from the pump, the tubing separated near the blue safety clamp and caused ivig blood products to leak and spray into the nurse's face and eyes.Due to the event the nurse had to go through the "blood product exposure process", however, occupational health determined that no blood work or prescribed medications were necessary due to the product being sterilized.The nurse states that her left eye remains irritated and itchy and she is planning to make an eye doctor appointment.There was no patient harm.

• 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: 7678076
• Report Number: 9616066-2018-00998
• Device Sequence Number: 10974913
• Product Code: FPA
• UDI-Device Identifier: 10885403232275
• UDI-Public: 10885403232275
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 06/13/2018

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: 10879047
• Device Catalogue Number: 10879047
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/10/2018; 10/18/2018
• 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: SEC TUBING, THERAPY DATE (B)(6) 2018
• Patient Age: 69 YR
• Patient Weight: 79