MAUDE Adverse Event Report: COVIDIEN "KANGAROO JOEY,PUMP W/POLE CLMP"; PUMP, INFUSION, ENTERAL

Model Number 383400

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Pain (1994)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; 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 Description

The customer stated that the kangaroo joey pump that she received was delivering at an increased rate.The user is unsure of the volume / rate set and the actual volume / rate delivered for this incident.This caused the user to have pain and feel sick; however, there was no medical intervention required as a result.The customer was unable to provide the serial number of the enteral feeding pump.The customer is unable to determine if the unit will be returned for service as she returned it to her medical equipment company.

• Brand Name: "KANGAROO JOEY,PUMP W/POLE CLMP"
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5084524970
• MDR Report Key: 8142998
• MDR Text Key: 130052123
• Report Number: 1282497-2018-08195
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1