PUMP FREEDOM 60

Report

• Report Number: MW5104527
• Event Type: Injury
• Date Received: October 8, 2021
• Report Date: September 29, 2021
• Manufacturer: REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
• Product Code: FRN
• Adverse Event: Yes
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PATIENT REPORTS FOR PAST 2 OR 3 INFUSIONS (SPECIFIC DATES NOT PROVIDED) EVERYTHING LOOKS GOOD ON INFUSION THEN PUMP DOES NOT MOVE, ONLY WORKS IF OPENS VERSARATE, IT WILL FLOW. AS THROUGH THE PUMP SPRING ISN'T STRONG ENOUGH TO PUSH MEDICATION THROUGH THE RESISTANCE OF THE SMALL HOLE. PATIENT MUST INFUSE MEDICATION SLOWER DUE TO SIDE EFFECTS OF NAUSEA. PUMP SERIAL NUMBER AND EXPIRATION DATE ARE UNKNOWN. UNKNOWN IF PATIENT EXPERIENCED ADVERSE EVENT OR MISSED DOSES. REPORTED TO (B)(6) BY PT/ CAREGIVER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1498958	PUMP FREEDOM 60	PUMP, INFUSION	FRN	REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS	F10050

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• Nausea

Product problems · 1

• Infusion or Flow Problem

Type of report · 1

• Initial submission