MAUDE Adverse Event Report: COVIDIEN UNKNOWN ENTERAL FEEDING PUMP

Model Number UNKNOWN ENTERAL FEEDING PUMP

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, a full report shall be provided.

Event Description

It was reported to covidien on (b)(6) 2016 that the customer experienced an issue with an enteral feeding unit.The customer states that the unit's alarm did not occur after all formula was fed, the pump continued to cycle and air was pumped.No patient harm.

Manufacturer Narrative

An investigation was performed for an unknown enteral feeding pump for the reported condition of the unit failing to alarm upon feeding completion and the unit continuing to cycle; causing air to be pumped.Several attempts were made to obtain information regarding the pump and it¿s availability for evaluation.To date, no additional information has been provided and the unit has not been returned for evaluation.Without the unit, a detailed investigation could not be performed and the reported condition could not be confirmed.Due to the lack of information regarding the enteral feeding pump, a device history record review could not be performed.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.

• Brand Name: UNKNOWN ENTERAL FEEDING PUMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5541993
• MDR Text Key: 41956346
• Report Number: 1282497-2016-00096
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

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 Model Number: UNKNOWN ENTERAL FEEDING PUMP
• Device Catalogue Number: UNKNOWN ENTERAL FEEDING PUMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 04/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1