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

Device Problems Break (1069); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Indication common variable immunodeficiency, unspecified.Pt reported her pump broke, the medication stopped pushing through the pump and she had to finish the infusion by hand.Pt did not miss a dose; no adverse event reported; device available for return; unknown lot/expiration.No further information known.Pump used to infuse hizentra 20% at dose/frequency above.Reported to (b)(6) by: patient/caregiver.

• Brand Name: FREEDOM 60-PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 11358028
• MDR Text Key: 233138295
• Report Number: MW5099518
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): Y
• 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: 01/04/2021

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 Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2021
• Patient Sequence Number: 1