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

Model Number 384500C

Device Problems Material Integrity Problem (2978); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

We received brand new replacement feeding pumps after having original equipment manufacturer (oem) refurbished pumps fail out of the box.Our facility has replaced out fleet of 150+ with oem refurbished pumps and are noticing a very high rate of error codes.Prior to placing these pumps into service, biomed conducted the initial inspections in the biotech testing mode.During these trials we used the same bags as were used during normal pm procedures for the previous failed pumps as well as additional new bags.Out of all the new pumps we had four which gave multiple error 37 and 39 with the various sets.Following these errors, we cleaned pump sensors and retested, two out of the four passed, cleaned sensors again and were then able to get passing test values.Since the reoccurring issue we encounter here, biomed conducted a 2nd test of the a sampling of 4 pumps again and instead of all passing; two pumps failed with error 37 and 39.Very high rate of out of the box issues with these and have been set aside until we receive additional guidance from oem.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 777 west st; mansfield MA 02048
• MDR Report Key: 13692156
• MDR Text Key: 286746392
• Report Number: 13692156
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 384500C
• Device Catalogue Number: 384500C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2022
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1095 DA