MAUDE Adverse Event Report: COVIDIEN LP KANGAROO; PUMP, INFUSION, ENTERAL

Model Number JOEY

Device Problems Excess Flow or Over-Infusion (1311); Calibration Problem (2890)

Patient Problem Overdose (1988)

Event Date 01/13/2017

Event Type  malfunction  

Event Description

It was reported that at approximately 0400, it was noted that there was not enough formula remaining to feed patient until 1200, when the next 24 hour volume would be delivered to the unit.It is suspected that the patient was receiving more volume per hour than the 22 ml/hr that the pump was programmed for.Pump was removed from service and a new pump was ordered and feed was restarted.It was reported that upon evaluation, the pump was found to be out of calibration and will be sent back to the manufacturer.Reportedly, there was no harm to patient.It was also reported that 4 days prior to this event, this pump was evaluated by clinical engineering at this facility and returned to service with no issues identified.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN LP; 444 mcdonnell blvd.; hazelwood MO 63042
• MDR Report Key: 6338811
• MDR Text Key: 67671488
• Report Number: 6338811
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: JOEY
• Other Device ID Number: 27196
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 5