MAUDE Adverse Event Report: COVIDIEN JOEY 1000ML PUMP SET; ENTERAL FEEDING PUMP SET

Model Number 763656

Device Problems Device Alarm System (1012); Disconnection (1171); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an enteral feeding pump set.The customer states that the finger tab continues to pop up, which will cause the pump to alarm with rotor error or not feed as programmed.The tubing is disconnecting at the mistic connector.The patient was underfed as a result.The caregiver needed to attempt to make up the difference during the daytime feeds.

• Brand Name: JOEY 1000ML PUMP SET
• Type of Device: ENTERAL FEEDING PUMP SET
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5996217
• MDR Text Key: 56807864
• Report Number: 1282497-2016-00771
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2016

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
• Device Operator: Lay User/Patient
• Device Model Number: 763656
• Device Catalogue Number: 763656
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1