MAUDE Adverse Event Report: MOOG / ZEVEX, INC. :URLIN 6000CMS - PUMP, STRENGTH: 20GM/200M; PUMP, INFUSION, ENTERAL

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

Inbound call from patient to check on her pump that was not working.Unknown if any doses were missed, lot number and expiration date unk.No further information is known or was reported.Reported to (b)(6) by pt/caregiver.

• Brand Name: :URLIN 6000CMS - PUMP, STRENGTH: 20GM/200M
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): MOOG / ZEVEX, INC.
• MDR Report Key: 10091688
• MDR Text Key: 192637264
• Report Number: MW5094686
• Device Sequence Number: 1
• Product Code: LZH
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• 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
• Patient Sequence Number: 1