MAUDE Adverse Event Report: EMED TECHNOLOGIES CORPORATION EMED SCIG60 INFUSER AMBULATORY PUMP; IMMUNOGLOBULIN G (IGG) INFUSION SYSTEM

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2019

Event Type  malfunction  

Event Description

Pt infused subq hizentra dose over 15 mins, however, the calculated infusion per versarate calculator should have lasted roughly 2 hours.Pt infused using infuset 930 tubing and scig60 pumps.Infusion was done with nurse on hand administering the infusion.Integrated medical systems.Fda safety report id# (b)(4).

• Brand Name: EMED SCIG60 INFUSER AMBULATORY PUMP
• Type of Device: IMMUNOGLOBULIN G (IGG) INFUSION SYSTEM
• Manufacturer (Section D): EMED TECHNOLOGIES CORPORATION
• MDR Report Key: 8515231
• MDR Text Key: 142217604
• Report Number: MW5085862
• Device Sequence Number: 1
• Product Code: PKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 57 YR
• Patient Weight: 79