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

Catalog Number 384400

Device Problems No Audible Alarm (1019); Improper Flow or Infusion (2954); Material Deformation (2976)

Patient Problems Irritability (2421); Underdose (2542)

Event Date 06/26/2018

Event Type  malfunction  

Event Description

Nurse placed 110 ml in the feeding bag of the connect feeding pump.The pump was programmed to deliver 96 ml to patient over one hour.At the end of the hour, the pump indicated 96 ml was delivered, yet, visually it appears as though half or more of the feed was remaining in the bag.The nurse noted a kink in the tubing at the top of the cassette.The patient was irritable after the feeding.We ran an experiment after the feeding and confirmed that the tubing was kinked and the pump does not alert for occlusion.The pump was observed while running the test feed for a few minutes and the pump indicated that 10 ml was delivered, yet we measured that only 2 ml was delivered.This new model pump was recently implemented at this hospital.There had been other complaints from our staff that the connect pump was not delivering the feeds properly.The connect was removed from service.The pump specifications in the instruction for use (ifu) would be appropriate for use with adult and pediatric patients.Specifications are 1 ml increments and an accuracy of 5 percent or 0.5 ml/hr whichever is larger, for all delivery rates no matter the type of kangaroo connect feeding set.Covidien may offer new software that corrects for erroneous cassette errors that interrupt feeds as well, but the new software does not address significant issues discovered such as the following: 1.Inaccurate volume delivered data after an occlusion.2.Inaccurate and unreliable delivery.3.Tubing holder design does not prevent kinking at the pump outlet.4.Alarm volume is too low and non-adjustable.5.No "continue" feature to use when feed remains in the tubing and the patient needs to receive that trapped volume.Formulas that the connect pump did not reliably deliver from our experience are as follows: enfamil ar 22, compleat pediatric, compleat pediatric fortified with duocal, expressed breast milk fortified with nutramigen, formula with miralax added.Manufacturer response for enteral feeding pump, kangaroo (per site reporter).The district representative, the senior marketing manager and two research & development employees from covidien came to the hospital to round with staff to try to understand the issues.Covidien provided a summary of issues, however the summary did not provide solutions to all of the issues.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 7850989
• MDR Text Key: 119381067
• Report Number: 7850989
• Device Sequence Number: 0
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2018,07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 384400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2018
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 DA
• Patient Weight: 6