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

Device Problems Failure to Infuse (2340); No Flow (2991); Output Problem (3005)

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

Event Type  malfunction  

Event Description

Indication: non familial hypo gamma globulin hernia.Patient stating that freedom pump has stopped working during infusion.Patient has taken out syringe twice and tried to get pump working again, but medication is still not flowing through tubing.Walked patient through manual push so hizentra infusion can be completed today.Pt did not miss a dose; no adverse event reported; device available for return; unknown lot/expiration.No further information known.Spontaneous call.Pump used to infuse hizentra 20% at dose and frequency above.Reported to (b)(6) by: patient /caregiver.

• Brand Name: PUMP FREEDOM 60
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): RMS MEDICAL / REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 11540998
• MDR Text Key: 241745016
• Report Number: MW5100141
• 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: 02/25/2021

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: 03/19/2021
• Patient Sequence Number: 1