MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO; PUMP, INFUSION, ENTERAL

Model Number	382400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the j tube feeding pump malfunctioned and the wrong amount of feeding fluid was administered to the patient.Per additional information provided on 21nov2024, the patient was over fed.The volume set to be infused was 1000 ml with a rate of 45 ml/hr but 820 mls were delivered in four hours.The patient was fed via j-tube and kangaroo epump enplus spike set with flush bag (ref 775100, lot 2423300145).This was the first time the set was used.The formula used was osmolyte 1.5.In the facility, an ambubag was utilized and then the resident was transferred to the hospital with emts.The patient died on (b)(6) 2024.Per the initial reporter, at this time there is no confirmation that the reported event is associated with the patient death.The initial reporter stated there is a possibility of human error and the pump may not have been reset/programmed between patients.The patient is believed to have had existing health issues and may have been para/quadriplegic; however, the initial reporter was not able to provide details.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the j tube feeding pump malfunctioned and the wrong amount of feeding fluid was administered to the patient.Per additional information provided on (b)(6) 2024, the patient was over fed.The volume set to be infused was 1000 ml with a rate of 45 ml/hr but 820 mls were delivered in four hours.The patient was fed via j-tube and kangaroo epump enplus spike set with flush bag (ref: (b)(4), lot: 2423300145).This was the first time the set was used.The formula used was osmolyte 1.5.In the facility, an ambubag was utilized and then the resident was transferred to the hospital with emts.The patient died on (b)(6) 2024.Per the initial reporter, at this time there is no confirmation that the reported event is associated with the patient death.The initial reporter stated there is a possibility of human error and the pump may have not been reset/programmed between patients.The patient is believed to have had existing health issues and may have been para/quadriplegic; however, the initial reporter was not able to provide details.Per additional information provided on 09dec2024, it is unknown how the overfeed contributed to an ambubag being utilized or the resident going to the hospital with emts.The cause of death is also unknown.The facility does not get any official information back when a death has occurred outside of the facility and they have not seen the death certificate.
Additional Manufacturer Narrative
The device history record was reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.The unit has never been returned for service, so there is no service history.The unit was not received for evaluation.It was not possible to determine the root cause of the reported condition.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: KANGAROO
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20865183
• Report Number: 1423537-2024-00336
• Device Sequence Number: 8688347
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: (01)10884521006614
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K040196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2025

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
• Operator of Device: Health Professional
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 12/06/2024; 12/09/2024; 01/30/2025
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White