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

Medical Device Problem Codes	Unintended Ejection (1234); Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Spontaneous call patient and husband called in to advise that they had a syringe eject from the freedom pump and now pump seem to be malfunctioning and infusing quicker than usual.Patient requesting replacement pump to be sent for next infusion.Patient understands that they did not quite get the tubing secured at the end of the pump, but now the pump is malfunctioning.Unknown if pt missed a dose; no adverse effects reported; we are sending a box for pump return; unknown lot/expiration.No further information known.Pump used to infuse 10 grams of gamunex-c 10% subcutaneously every week.Indication: common variable-immunodeficiency, unspecified.Reported to (b)(6) by pt/caregiver.

• Brand Name: FREEDOM 60-PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 10770289
• Report Number: MW5097586
• Device Sequence Number: 10281607
• Product Code: FRN
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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
• Operator of Device: No Information
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2020
• Patient Sequence Number: 1