MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL

Model Number 383400

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Fever (1858); Nausea (1970); Tachycardia (2095)

Event Date 01/18/2019

Event Type  Injury  

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer stated that the enteral feeding pump was set to deliver 280ml bolus of jevity 1.2 every 4 hours however the pump delivered the entire 1000cc in no more than 4 to 4.5 hours.The patient became tachycardic, febrile and nauseated; potential aspiration.500ccs of measured gastric residual was removed via syringe.The patient¿s gastric residual volume amount leading up to being reportedly overfed was 0.It is not known if the previous pump settings reset or cleared prior to initiating this feeding.The product code and lot number of the feeding set is unknown.It is not known when/if the rate changed.The kangaroo feeding bag was used at the correct head high per instructions and the tube was not overstretched during the installation.The patient was on reglan prior to this incident.The patient was being fed for greater than 1 week and was not a diabetic.Feedings were not resumed after the gastric residuals were removed.

Manufacturer Narrative

The device from this complaint was returned and evaluated.The reported issue of the over feed delivery could not be confirmed based on the returned sample.The possible root cause for the condition could not be determined based on the limited information.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.As part of continuous improvements, a corrective action has been opened to further investigate this report and to implement effective solutions to prevent reoccurrence of this issue.

• Brand Name: KANGAROO JOEYPUMP W/POLE CLMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 8313389
• MDR Text Key: 135336750
• Report Number: 1282497-2019-08256
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other