MAUDE Adverse Event Report: NESTLE HEALTHCARE NUTRITION, INC. COMPAT ENTERAL FEEDING PUMP; PUMP, INFUSION, ENTERAL

Catalog Number 19923500

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Aspiration/Inhalation (1725)

Event Type  Injury  

Event Description

Report states patient aspirated while on the enteral feeding pump.Free flow alarm did go off when the patient aspirated.

• Brand Name: COMPAT ENTERAL FEEDING PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): NESTLE HEALTHCARE NUTRITION, INC.; 12500 whitewater drive; minnetonka MN 55343
• Manufacturer Contact: connie stapel ; 12500 whitewater drive; minnetonka, MN 55343 ; 9528486000
• MDR Report Key: 4840066
• MDR Text Key: 17333401
• Report Number: 2110851-2015-00001
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 0891575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2015

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: Other
• Device Catalogue Number: 19923500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADMINISTRATION SET
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR