MAUDE Adverse Event Report: COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL

Model Number UNKNOWN ENTERAL FEEDING SET

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that the epump en plus spike with flush bag tubing is leaking and the purple piece is disconnecting easily.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.One used sample was received for evaluation.The sample was visually evaluated.The sample was found clogged with dry formula along the pvc lines that obstructed the tube path at the valve level, therefore no functional evaluation could be performed since the product could not be unclogged.No fault was found related to manufacturing; possible root cause could be incorrect formula inside the tube or incorrect homogenization process for the formula but since the sample was received on inadequate conditions root cause could not be verified.No corrective actions will apply since failure mode was not confirmed related to manufacturing, it will be confirmed as unknown source.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7278508
• MDR Text Key: 100455664
• Report Number: 9610849-2018-00015
• 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: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

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: Health Professional
• Device Model Number: UNKNOWN ENTERAL FEEDING SET
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR