MAUDE Adverse Event Report: MOOG COSTA RICA, SRL CMS PUMP; PUMP, INFUSION

Model Number 6000

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Patient reports that infusion was running at a higher rate than pump programmed.Nurse stopped pump, replaced batteries, re-inserted tubing, but problem persisted.Nurse had to finish infusion using gravity drip.The product fault occur while in use with the patient.The product issue did not cause or contribute to patient or clinical injury.The device is available for investigation.The device was replaced.The patient did not have a backup device they were able to switch to, but used gravity drip to complete infusion.No missed dose or adverse event reported.Product lot number and expiration date not available.No further information provided.Indication: infuse 120gm [1200ml] intravenously divided over 5 days every 4 weeks.Indication: systemic lupus erythematosus, unspecified.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CMS PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MOOG COSTA RICA, SRL
• MDR Report Key: 16683852
• MDR Text Key: 312935819
• Report Number: MW5116343
• 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: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6000
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female