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

Model Number F10050

Device Problems Mechanics Altered (2984); Noise, Audible (3273)

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

Event Date 01/30/2023

Event Type  malfunction  

Event Description

Spontaneous call pt reported infusion was finished.Pump made pop sound in the end and dial does not work now per patient.No injuries or side effects reported.Does not have another pump on hard.Lot and serial not available.Pump return box and new pump will be sent to pt pump uses to infuse hizentra at the above dose and frequency.Indication: common variable immunodeficiency, unspecified.Reported to (b)(6) by pt/caregiver.

• Brand Name: FREEDOM PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 16294732
• MDR Text Key: 308836419
• Report Number: MW5114651
• 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: 01/30/2023

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: 02/02/2023
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male