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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RMS MEDICAL/REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS PUMP FREEDOM 60; PUMP, INFUSION
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RMS MEDICAL/REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS PUMP FREEDOM 60; PUMP, INFUSION Back to Search Results
Model Number F10050
Device Problem Infusion or Flow Problem (2964)
Patient Problems Unspecified Infection (1930); Ischemia Stroke (4418)
Event Type  Injury  
Event Description
Spoke with pt's wife who reports infection (pseudomonas).Md aware and pt also reported several transient ischemic attacks and then a stroke, md is aware, started eliquis and was hospitalized for unknown dates/length of stay.Pt then waited for 1 month to restart hizentra.Has had 2 doses since with no issues.Pump also may have an issue as infusions got slower.Took 20-30 minutes longer with last infusion.Pump lot/expiration unknown.No other info known.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.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.Patient was able to finish last infusion.Indication: common variable immunodeficiency, unspecified.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
PUMP FREEDOM 60
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
RMS MEDICAL/REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
mahwah NJ
MDR Report Key16132348
MDR Text Key307088467
Report NumberMW5114250
Device Sequence Number1
Product Code FRN
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberF10050
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Treatment
ELIQUIS; HIZENTRA
Patient Outcome(s) Hospitalization;
Patient SexMale
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