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

Model Number 772055

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that there is an issue with the tubing connections that caused leaking, prevented the formula from reaching the patient.This was noticed prior to use with the patient and the sets have been discarded.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the customer states that there is an issue with the tubing connections that caused leaking, prevented the formula from reaching the patient.This was noticed prior to use with the patient and the sets have been discarded.¿ a review of the device history record (dhr) for lot no.150230387x indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Twenty four (24) samples were received for evaluation.The samples were visually inspected and functionally tested.Visual inspection observed no pin hole or material detachment that could cause the reported event of leaking.All samples passed priming tests and executed the feeding process without alarm activation.A possible root cause for leaking could be a dimensional gap between the connector and tubing or detachment.This could occur if the tube or connectors be pulled incorrectly or if excessive force (unintentional) is utilized.The reported customer complaint is not confirmed.A root cause could not be determined.This complaint will be utilized 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: 7252297
• MDR Text Key: 99801457
• Report Number: 9610849-2018-00007
• 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: consumer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

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: 772055
• Device Catalogue Number: 772055
• Device Lot Number: 150230387X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2015
• 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