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

Model Number 6000 CMS

Device Problems Break (1069); No Flow (2991)

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

Event Type  malfunction  

Event Description

Per pt, pump broke during last infusion.The home health rn noticed that medication was not moving through tubing, and after attempting to troubleshoot, still could not get the pump to work.Infusion was finished via gravity.No missed dose; no adverse event reported; device available for return, unk lot/expiration.No further info known.Pump used to infuse gamunex-c 10% at above doses / frequency.Frequency: daily for 3 consecutive days every 4 weeks.Reported to (b)(6) by pt/caregiver.

• Brand Name: CURLIN 6000CMS PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MOOG INC. / ZEVEX, INC.
• MDR Report Key: 11702054
• MDR Text Key: 247003896
• Report Number: MW5100914
• 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: 02/22/2021

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
• Device Model Number: 6000 CMS
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2021
• Patient Sequence Number: 1