MAUDE Adverse Event Report: MOOG / KORU MEDICAL SYSTEMS FREEDOM 60; PUMP, INFUSION

Model Number	F10050
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Mom reported infusions are taking longer than normal for the last 2 infusions.She stated no changes to needles and tubing, but for some reason taking about 15 min longer to do.She declined altering needles and tubing and wanted to try to see if new pump would solve the issue.No missed doses reported, no adverse event reported, unknown if pump available for return.No known lot number, no known serial number of pump.Frequency: infuse 2gm(10ml)subcutaneously on week 1 and 1gm(5ml) on week 2, then repeat.[total 6gm/ 4 weeks].Indication: nonfamilial hypogammaglobulinemia.Reported to (b)(6) by pt/caregiver.

• Brand Name: FREEDOM 60
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): MOOG / KORU MEDICAL SYSTEMS
• MDR Report Key: 17436790
• Report Number: MW5120433
• Device Sequence Number: 2437487
• 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): 07/13/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HYPOGAMMAGLOBULINEMIA; TUBING
• Patient Sex: Female