MAUDE Adverse Event Report: Q CORE MEDICAL SAPPHIREPLUS

Model Number 15038

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Hyperglycemia (1905)

Event Date 12/04/2018

Event Type  Injury  

Event Description

Infusion pump programmed at 8.8ml/hr of d10, with max volume to infuse of 17.6 ml, noted jittery baby, hyperglycemia, and ml missing from bag.No alarm.Diagnosis or reason for use: maintenance fluid.Two rns working with pt state no unusual event occurred when iv bag hung.Interrogation of pump shows record that pump was set correctly.Pt required transfer to higher level of care nicu.

• Brand Name: SAPPHIREPLUS
• Type of Device: SAPPHIREPLUS
• Manufacturer (Section D): Q CORE MEDICAL ; 29 yad haruzim st.; po box 8639; netanya 42505 29; IS 4250529
• MDR Report Key: 8189486
• MDR Text Key: 131373356
• Report Number: 8189486
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: 15038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/05/2018
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 1 DA
• Patient Weight: 2