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

Model Number 382400

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

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.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 reported that the device was infusing more than requested.Additional information was received stating that the issue occurred during testing.They conducted the test according to the service manual.There was no specific volume set to be infused, but after 30 minutes of running, the pump is expected to deliver between 33.7 ml to 41.3 ml and the rate was set at 75ml/hr.The actual volume delivered was 44ml.They measured the amount of water delivered by the pump after it ran for 30 minutes.The rate of the feed was never changed.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed.The reported issue could not be confirmed.The device was functional during the evaluation.The unit¿s software was updated as a preventative measure.The battery was replaced because it was obsolete.The power connection label was damaged and replaced due to due to opening the unit.The rotor¿s rollers were found stuck and replaced.The sensor was replaced due to a feed error.The gearbox encoder was worn and replaced.The serial number label, 3m bump, hinge label, tyvek and vinyl foot were replaced due to opening the back housing.The back housing was replaced as well.No further actions are required at this time.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12280420
• MDR Text Key: 265151067
• Report Number: 1282497-2021-10532
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: 10884521006614
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1