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

Model Number	383401
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
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 was over dispensing the set volume.The pump was running fast.No further details were provided.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information provided by the customer.An evaluation of the kangaroo pump was performed.The unit was triaged, and the reported issue could not be confirmed at this time.The unit did alarm when the feeding set was removed, it did alarm when the tubing was crimped, it also passed the mystic test, and the accuracy test using 125ml of water; the delivered rate was as expected and within tolerance specifications.The unit was serviced by updating the software and replacing the damaged gearbox as encoders #2 and #3 were worn, the damaged pcb which had d15 lifted, the out-of-date battery, and the gasket and tie due to opening the unit.No further actions are required at this time.Complaint trending information is being reviewed on a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.
Event or Problem Description
The customer reported that the device was over dispensing the set volume.The pump was running fast.No further details were provided.Additional information was received stating that they just ran the unit at 400ml rate at 100ml volume into a graduated cylinder and got 130ml.

• 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: 11583333
• Report Number: 1282497-2021-10014
• Device Sequence Number: 4766934
• Product Code: LZH
• UDI-Device Identifier: 10884521144019
• UDI-Public: 10884521144019
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/18/2021

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: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 10/18/2021
• Patient Sequence Number: 1