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

Model Number 383400

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 09/06/2021

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 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
• 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: 12481683
• MDR Text Key: 271707866
• Report Number: 1282497-2021-10620
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2021
• Type of Device Usage: N
• Patient Sequence Number: 1