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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Event Description

Indication: chronic inflammatory demyelinating polyneuritis.Spontaneous, pt stated curlin pump sn#(b)(4) sent 10/26/22 was not working so his nurse ordered another.Pt still has old pump, so may be able to finish the infusion.No info available about injury since nothing mentioned while ordering new pump.No lot# or expiration date available.Unknown if patient experienced any adverse events.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CURLIN 6000 PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ZEVEX INC., (DBA MOOG MEDICAL DEVICES GROUP)
• MDR Report Key: 16003830
• MDR Text Key: 305874970
• Report Number: MW5113843
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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
• Treatment: TUBING..
• Patient Sex: Male