MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ORANGE INFINITY EFP; ENTERAL FEEDING PUMP

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Not Applicable (3189)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

Info indicates device continues to run after prescribed dose is administered during test.No pt impact indicated.

Manufacturer Narrative

Device not returned for eval as of (b)(4) 2014.

• Brand Name: ORANGE INFINITY EFP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; salt lake city UT
• Manufacturer Contact: katherine kenner, sr, specialist ; 4314 zevex park ln.; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 4201093
• MDR Text Key: 20784558
• Report Number: 1722139-2014-00140
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1