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

Model Number 6000CMS

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  malfunction  

Event Description

Indication: hereditary hypogammaglobulinemia.Spontaneous call from nurse ((b)(6)) to report that she put new batteries twice in the curlin pump but got an error ¿internal battery impaired¿.New pump will be sent out and malfunctioning device will be returned.Infusion completed, no adverse even reported.No further information provided.Reported to (b)(6) by: patient/caregiver.

• Brand Name: PUMP CURLIN 6000 CMS
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MOOG/ZEVEX, INC.
• MDR Report Key: 9538831
• MDR Text Key: 173507428
• Report Number: MW5091959
• 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
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6000CMS
• Device Lot Number: 15414937
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 16 YR