MAUDE Adverse Event Report: MOOG, INC./ZEVEX, INC. ENTERALITE INFINITY FEEDING PUMP; PUMP, INFUSION, ENTERAL

Device Problem Melted (1385)

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

Event Date 03/23/2019

Event Type  Injury  

Event Description

Patient¿s mother called stating that the charging cord ¿melted¿ into the charging port on infinity feeding pump.They were able to remove the cord, but it will no longer charge when plugged back in.

• Brand Name: ENTERALITE INFINITY FEEDING PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): MOOG, INC./ZEVEX, INC.
• MDR Report Key: 8471126
• MDR Text Key: 140614911
• Report Number: MW5085459
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 MO
• Patient Weight: 11