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

Model Number	382400
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Dyspnea (1816); Pneumonia (2011); Vomiting (2144); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 health effect - clinical code 4581 - bloating.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1282497-2023-10799
• Device Sequence Number: 6995086
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: 10884521006614
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 45 KG