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

Model Number 382400

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The customer report an issue with an enteral feeding pump.Upon triage, a thermal issue was found consisting of burnt component q28 in the motor failsafe circuit of the pcba.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the customer reports the pump has no power.Upon triage, a thermal issue was found consisting of burnt component q28 in the motor failsafe circuit of the pcba.¿ the device history record (dhr) for serial number (b)(4) indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Product cannot be released unless it passes all quality and conformance requirements.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.One (1) kangaroo epump was returned for evaluation.Upon receipt, it was observed the pump did not have a pole clamp, battery and power cord.The screw seal was missing and the ultrasonic housing was improperly mounted on the main housing.The unit was not able to power up on the fi battery power and on ac power.Internal inspection and investigation reveals a blown fuse and a burnt component in the motor failsafe circuit of the pcba.Also, the improper mounting of the gearbox caused the encode wheel to barely rub against the battery housing.The gearbox shaft had observable black residue.The reported issue of no power was confirmed.A thermal issue was further confirmed upon unit servicing.A root cause was determined to be a blown fuse and a burnt component in the motor failsafe circuit of the pcba.No further corrective action is required at this time.This complaint will be recorded 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; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 8031132
• MDR Text Key: 125907245
• Report Number: 3006451981-2018-00623
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: 10884521006614
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1