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

Device Problems No Display/Image (1183); No Flow (2991)

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

Event Type  malfunction  

Event Description

Solicited call from (b)(6), home health nurse, who reported that pump stopped infusing at step 3, screen is completely wiped out and was beeping.She said that she would administer the remainder of the infusion (110ml) manually and requested a replacement pump.No lot number er expiration date was provided.No missed dose or side effects reported.Not specified if defective pump is still on hand for return.No further information reported.Reported to (b)(6) by health professional.

• Brand Name: CURLIN 6000CMS-PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MOOG / ZEVEX, INC.
• MDR Report Key: 11364847
• MDR Text Key: 233277899
• Report Number: MW5099537
• 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: 01/07/2021

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 Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2021
• Patient Sequence Number: 1