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

Device Problem Decreased Pump Speed (1500)

Patient Problems Erythema (1840); Subcutaneous Nodule (4548)

Event Type  Injury  

Event Description

Patient reports pump was running slower than typical.Pt also reported redness and bumps near infusion sites.Redness and bumps are not serious and normal with infusions.Pump replaced.Lot number, expiration date, model number, and serial number are not known as they were not provided.Patient did not have pump available at time of call.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.If yes, was any medical intervention provided? n/a.Is the actual device available for investigation? yes.Did we replace the device? yes.Did the patient have a backup device they were able to switch to? no, but pt was able to finish infusion anyway.No other information known.Reported to cvs/caremark by pt/caregiver.

• Brand Name: FREEDOM PUMP 60
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 16043527
• MDR Text Key: 306277448
• Report Number: MW5113990
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: HIZENTRA
• Patient Sex: Female