MAUDE Adverse Event Report: COVIDIEN KANGAROO CONNECT FEEDING SET 500 ML; PUMP, INFUSION, ENTERAL

Model Number	77500FD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that a child was receiving feed via a kangaroo connect pump overnight and at approximately 0400h staff noted that the feed had leaked into the bed.The staff member was unable to measure the loss of feed but noted the bg to be low.The child is iddm and required a syrup bolus as rescue medication for hypoglycemia.The staff estimated that this occurred on the third day of use.There was no other medical intervention provided beyond the syrup bolus.The patient responded well to the syrup bolus and their symptoms resolved.There are no known further complications at this time.

• Brand Name: KANGAROO CONNECT FEEDING SET 500 ML
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9695615
• Report Number: 1282497-2020-08923
• Device Sequence Number: 1942356
• Product Code: LZH
• UDI-Device Identifier: 10884521190849
• UDI-Public: 10884521190849
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 77500FD
• Device Catalogue Number: 77500FD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1