MAUDE Adverse Event Report: MOOG MEDICAL DEVICES ENTERALITE INFINITY FFP; ENTERAL FEEDING PUMP

Model Number INFINITY EFP

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)

Patient Problem No Code Available (3191)

Event Date 08/28/2014

Event Type  malfunction  

Event Description

Information indicates that pump was overdelivering and not stopping when the food had run out.Info indicates this has occured multiple times sine the device was removed from it's box.No impact to the pt suggested.

• Brand Name: ENTERALITE INFINITY FFP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): MOOG MEDICAL DEVICES; salt lake city UT
• Manufacturer Contact: katherine kenner, regulatory specia ; 4314 zevex park ln.; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 4284149
• MDR Text Key: 18732245
• Report Number: 1722139-2014-00148
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: INFINITY EFP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Report to Manufacturer: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PEPTAMINE JR
• Patient Age: 7 YR
• Patient Weight: 17