MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/CLMP,REFB; PUMP, INFUSION, ENTERAL

Model Number	383401
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the device is continuously feeding causing an over delivery outside of the accuracy limit.
Additional Manufacturer Narrative
Evaluation summary all device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.The device was returned and evaluated at the regional service center.The device was tested for the reported condition and passed all testing.The reported issue could not be confirmed.A root cause could not be determined based on the device return and no corrective action is necessary at this time.Complaint trending information is reviewed on a routine basis and if a trend is observed, actions will be taken as necessary.

• Brand Name: KANGAROO JOEY,PUMP W/CLMP,REFB
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9179082
• Report Number: 1282497-2019-08710
• Device Sequence Number: 11416809
• Product Code: LZH
• UDI-Device Identifier: 10884521144019
• UDI-Public: 10884521144019
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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
• Operator of Device: No Information
• Device Model Number: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 01/02/2020
• Patient Sequence Number: 1