MAUDE Adverse Event Report: ZEVEX INCORPORATED (DBA MOOG MEDICAL DEVICES GROUP) CURLIN 6000; PUMP, INFUSION

Device Problem Pumping Stopped (1503)

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

Event Type  malfunction  

Event Description

Pt's grandmother reported curling 6000 keeps stopping and beeping during the infusion for aldurazyme.Flashing an error message which reads "contact provider." infusion nurse, joelle w.Must turn pump off and on to restart it.Patient received this pump 3 weeks ago, but last week, it started malfunctioning.They are able to complete the infusion.Infusion nurse is not sure what causes it to do that and seems completely random.New pump along with pump return box being sent to pt.No additional information available.Pump used to infuse aldurazyme at above dose and frequency.Reported to (b)(6) by pt/caregiver.

• Brand Name: CURLIN 6000
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ZEVEX INCORPORATED (DBA MOOG MEDICAL DEVICES GROUP)
• MDR Report Key: 16630168
• MDR Text Key: 312284619
• Report Number: MW5116036
• 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: 03/23/2023

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 Expiration Date: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2023
• Patient Sequence Number: 1
• Treatment: ALDURAZYME; TUBING
• Patient Sex: Male