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

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The patient's mother reported that the pump beeps the entire time they are infusing.The product fault occurred when in use with the patient.Unsure if the issue caused patient or clinical injury.Unsure if device is available for investigation.Device will be replaced.Unsure if patient had backup device that the patient was able to switch to.The device lot number/serial number and expiration date are unknown.No further details are available.Indication: common variable immunodeficiency, unspecified; nonfamilial hypogammaglobulinemia.Reported to (b)(6) by pt/caregiver.

• Brand Name: PUMP CURLIN 6000CMS
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MOOG / ZEVEX, INC.
• MDR Report Key: 16743646
• MDR Text Key: 313412889
• Report Number: MW5116636
• 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: 04/13/2023
• 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
• Treatment: CASSETTE ; HYPOGAMMAGLOBULINEMIA; TUBING
• Patient Sex: Female