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

Model Number	383400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
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 an error with the feeding pump occurred.The registered nurse noticed that the patient was receiving his tube feedings at a higher rate than ordered.Upon the nurse's previous assessments, the patient was receiving 45ml/hr as ordered.When the error was noticed at around 0600, the patient was receiving 200ml/hr.The feeding was held, residuals were checked and were 500ml, and blood glucose was also checked.The icu nurse and physician were notified.Orders were received for lantus and lispro for one-time doses.

• Brand Name: KANGAROO JOEYPUMP W/POLE CLMP
• 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: 12758712
• Report Number: 1282497-2021-10654
• Device Sequence Number: 11843890
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2021

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: 383400
• Device Catalogue Number: 383400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/07/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male