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

Model Number	382400
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 overfeeding.Additional information was received from the customer that the volume to be infused was set to 150 ml/hr.In 15 minutes the device delivered 41.53 ml which is not within +/- 10%.33.75 to 41.25 , 1 ua leakage.They tightened pole mount screw and ran the pump 3 times and every time the output was out of tolerance over 41.25 max variance.No patient was involved.They used distilled water to test the device.The device failed the preventative maintenance.
Additional Manufacturer Narrative
The service history record was reviewed showing no previous issues.The unit was tested and passed all testing.The unit was specifically tested for accuracy and passed; the rate was as expected.The reported condition could not be confirmed.No corrective action is required at this time.The unit was functioning properly during evaluation.Preventative maintenance was performed on the unit due to damage to the housing.This complaint will be used for tracking and trending purposes.

• Brand Name: KANGAROO EPUMP - NEW
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12189846
• Report Number: 1282497-2021-10497
• Device Sequence Number: 1480334
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: 10884521006614
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 10/14/2021

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: 07/13/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1