MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO ENTERAL FEED PUMP; PUMP, INFUSION, ENTERAL

Device Problems Labelling, Instructions for Use or Training Problem (1318); Therapeutic or Diagnostic Output Failure (3023); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2019

Event Type  Death  

Event Description

(b)(6) was totally dependent for nourishment on her peg implant, necessitated by a throat operation to remove cancerous tissue.The feed pump system, intended for home-use, provided by valley view hospital continually failed because of bubbles in the tubing.Every bubble had to be squeezed along the tubing and vented at a hand- controlled valve located just prior to the entrance to the patient's stomach.With no training or guidance, apart from the printed instructions, this became a 24/7 nightmare that continued for 59 days.Provided to (b)(6) hospital by aveanna medical solutions.

Event Description

Additional information received from reporter on 7/8/2021 for report mw5100869.The kangaroo enteral feed pump, provided by (b)(6) hospital in (b)(6), did not suffer mechanical or electrical incidents.The device never worked in the first place.Lacking instructions or experience, i assumed that the malfunctioning of the pump was caused by my ineptitude.I examined the tubing at the hospital and could not understand why bubbles and stoppages in their tubing were not an issues for the nurses.Letters dated (b)(6) 2021 and (b)(6) 2019 that provide additional information.(b)(6) was totally dependent on the feed pump for 59 days until her death on (b)(6) 2019.(b)(6) tells us that she has no energy and is fatigued.(b)(6) states that she vomits due to a gag reflex multiple times throughout the day.

• Brand Name: KANGAROO ENTERAL FEED PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 11700011
• MDR Text Key: 246692082
• Report Number: MW5100869
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 06/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 76 YR
• Patient Weight: 60