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

Device Problem No Flow (2991)

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

Event Type  malfunction  

Event Description

Spontaneous call.Patient reported that the pump broke during her infusion.She was not able to infuse her medication.No adverse event reported; device available for return; unknown lot/expiration.No further information known.No dates known.Indication: other common variable immunodeficiencies.Pump is used to give hizentra 20% 10 grams sc twice a week.Reported to (b)(6) by pt/caregiver.

• Brand Name: FREEDOM 60-PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): RMS MEDICAL / / REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 10945704
• MDR Text Key: 220008729
• Report Number: MW5098197
• 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: 11/24/2020

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: 12/03/2020
• Patient Sequence Number: 1