MAUDE Adverse Event Report: MOOG MEDICAL / ZEVEX, INC. CURLIN 6000CMS PUMP; PUMP, INFUSION

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Event Description

Spontaneous communication from (b)(6), the patient's home health rn, who reported that the patient's pump is showing "system timeout".The home health rn replaced the batteries, restarted the pump, connected and disconnected tubing and the error still shows.After consulting with several other pharmacists, they determined there is no way to reset the pump and a new pump is needed.The home health rn will infuse via gravity today and a new pump is scheduled for tomorrow.Infusion was manually completed and the patient did not miss any doses.There were no adverse events as a result of the product complaint.The defective device is being returned to cvs and a new pump is being shipped to the patient.The lot number and expiration date are unknown.No further information is available.Dose or amount and frequency: infuse 80gm (800ml) intravenously, daily for 2 days, every 2weeks.Indication: myasthenia gravis and other myoneural disorders.Reported to (b)(6) by health professional.

• Brand Name: CURLIN 6000CMS PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MOOG MEDICAL / ZEVEX, INC.
• MDR Report Key: 16771086
• MDR Text Key: 313658458
• Report Number: MW5116830
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): Y
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female