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

Model Number	382400
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
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 infuses too fast.The volume to be infused (vtbi) outside of spec.Additional information was received stating that the exact amount is unknown, it was at least 5 ml overfed.The volume to be infused was set to 30 ml and the rate was set to 60 ml/hr.The actual volume delivered was greater than 30 ml and the feed was completed in.5 hours.
Additional Manufacturer Narrative
The service history record was reviewed and indicated that this is the first time that this unit has been returned for service.An evaluation of the kangaroo pump was performed.The unit was triaged, and the reported issue was confirmed.After review, it was determined that the us sensor was damaged (based on error code index list: ultrasound voltage when tube is full in a/d counts).The sensor was replaced, and the problem was resolved.Also, battery was damaged due to obsolete, rotor damaged due to rollers not spinning freely.Gear box was damaged due to worn encoder 2, front housing damaged, back housing damaged due to screw boss area broken.Overlay, badge was replaced due to front housing replacement.Bump, hinge label, vynil foot and sn label were replaced due to back housing replacement.Power connection label replaced due to opening of the unit.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
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12193604
• Report Number: 1282497-2021-10498
• Device Sequence Number: 20045544
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: 10884521006614
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1