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

Model Number 382400

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Dyspnea (1816); Pneumonia (2011); Vomiting (2144); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/02/2023

Event Type  Injury  

Manufacturer Narrative

H6 health effect - clinical code 4581 - bloating.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the device did not stop feeding.The patient was sent to the er and returned the same day.Additional information was received on 11sep2023 confirming that the device did not stop at the set volume of 250ml and has failed to alarm upon feeding completion.The rate was set to 250 ml/hour; the actual volume delivered was 839 ml and was fed for 3.3 hours.They did not know when or if the rate of the feed had changed.The formula used was nutren 2.0 via g tube and delivered while the patient was in a sitting position.The patient experienced vomiting, bloating, and difficulty breathing and was sent to the er as a result of the event.The patient was diagnosed with aspiration pneumonia.The patient was suctioned and was prescribed augmentin 875, twice a day for 7 days.It was unknown if the patient had metabolic problems.The patient had an existing condition of huntington's disease and was now stable and improving.Additional information received on 20sep2023 confirmed that the intended feeding was 250ml/hr for 1 hour x 1.The volume of formula was 1000ml prefilled.They believe the mode of the pump at the time of the incident was continuous.The volume programmed for the vtbd was 250ml.The treatment provided in the ed for the vomiting and the bloating was feeding held.The treatment provided in the ed for the difficulty breathing was suctioning, antibiotics.

Manufacturer Narrative

The device was returned for evaluation and was functionally tested.The feeding pump performed as expected with no failures found.Based on the information available to us, we were unable to confirm the event.All information received will be used for further tracking and trending purposes.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17888954
• MDR Text Key: 325135749
• Report Number: 1282497-2023-10799
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: 10884521006614
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 45 KG