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

Device Problem Air/Gas in Device (4062)

Patient Problems Abdominal Pain (1685); Arrhythmia (1721); Dehydration (1807); Fever (1858); Hypoglycemia (1912); Vomiting (2144); Electrolyte Imbalance (2196); Lethargy (2560); Abdominal Distention (2601); Weight Changes (2607)

Event Type  Injury  

Event Description

An attorney reported that in around 2020, a patient began to experience complications with her feeding.As it turns out, her enteral feed pump set was allowing air to enter the tubing, which was causing vomiting, dehydration, hypoglycemia, abdominal pain, and abdominal distention in patients.On (b)(6), 2020 the patient was brought to the emergency department because she was lethargic, limp and feverish.She was found to have electrolyte abnormalities due to feeding intolerance.As a result of the electrolyte issues, she was also suffering from arrhythmia.In addition, she was documented as being dehydrated, hypoglycemic, vomiting, suffering from increased abdominal distention and had lost weight.She was hospitalized until (b)(6), 2020.Since then, the patient has continued to struggle with abdominal pain and distention, which have resulted in weight loss and intolerance to feeding.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: KANGAROO
• 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: 17777205
• MDR Text Key: 323768162
• Report Number: 1282497-2023-10795
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 11 YR
• Patient Sex: Female