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

Model Number	11484001
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.The customer stated that the patient was an infant patient.
Event or Problem Description
It was reported that the tubing set unintentionally disconnected twice from the precedex iv bag during use on the same baby in the nicu.
Additional Manufacturer Narrative
Correction: initial reporter health professional; initial reporter occupation.Additional information;evaluation codes.No product will be returned per customer.The customer complaint of tubing set unintentionally disconnected from iv bag could not be confirmed due to the product was not returned for failure investigation.A photo of packaging pouch was provided by the customer, however; it does not confirm complaint of tubing set unintentionally disconnected from iv bag.The root cause of this failure was not identified as no product was returned.
Event or Problem Description
It was reported that the tubing set unintentionally disconnected twice from the precedex iv bag during use on the same baby in the nicu.

• 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: 8940791
• Report Number: 9616066-2019-02425
• Device Sequence Number: 335343
• Product Code: FPA
• UDI-Device Identifier: 10885403232299
• UDI-Public: 10885403232299
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: 11484001
• Device Catalogue Number: 11484001
• 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: 08/28/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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: 8015, 8100, TD 08/05/2019.