MAUDE Adverse Event Report: KORU / REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS FREEDOM PUMP 60; PUMP, INFUSION

Model Number F10050

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2023

Event Type  malfunction  

Event Description

Igrx - pt states pump stops working during the infusion and she doesn't get all the ig, this has been happening for the past month.States her md is aware of pump not working and her not getting all her infusion.She states md hasn't given her instruction for any make up doses.No side effects reported.Pt is to return pump and replacement pump being sent.Pump used to infuse hizentra at the above rate and dose.No add'l info available.Device serial not provided.Indication: common variable immunodeficiency, unspecified.Reported to (b)(6) by pt/caregiver.

• Brand Name: FREEDOM PUMP 60
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): KORU / REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 16664542
• MDR Text Key: 312624735
• Report Number: MW5116223
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• 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: 03/29/2023

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
• Device Model Number: F10050
• Device Catalogue Number: F10050
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2023
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female