MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL

Model Number	383400
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
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 was infusing over feeding.Additional information was received and stated that during feeding, the nurse noticed that the feeding bag was getting empty sooner than expected.Per customer, nasogastric tube (ngt) was used on the patient for delivery and 1000ml of formula into the bag was loaded, expecting it to be empty after 8.33 hours, but it was emptied sooner, with the actual volume infused not aligning with the amount the pump said it infused.The patient was overfed for about 10% and the customer further stated that the volume to be infused was set to 1800 ml with rate set to 120 ml/hr.The actual volume delivered was 2000 ml and the feed was completed in 15 hours.Per customer, the device was tested and upon testing the device, the pump infused 59 ml of water in 30 minutes, when set to 100ml/hr.The patient was not metabolic.There was no adverse event reported and no medical intervention was required.

• Brand Name: KANGAROO JOEYPUMP W/POLE CLMP
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12481683
• Report Number: 1282497-2021-10620
• Device Sequence Number: 11696618
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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: Health Professional
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/16/2021
• Patient Sequence Number: 1