MAUDE Adverse Event Report: COVIDIEN EPUMP INTL PRX SPK FD 1000ML; ENTERAL FEEDING PUMP SET

Model Number 674669

Device Problem Disconnection (1171)

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

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 06/01/2016.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 equipment disconnected from the extension.

Manufacturer Narrative

A device history record was not performed; no lot number was provided or available.No sample or picture was provided for evaluation.Possible root causes could be: stretching peristaltic tubing before usage, incorrect placement in pump causing additional stress to the tubing and detachment, enfit female connector is not correctly adjusted to the transition connector and transition connector is not placed correctly to the g-tube or other tube that could go directly to the patient.No corrective actions will apply since the failure mode has not been confirmed to be any manufacturing issue with samples that have been received from previous investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP INTL PRX SPK FD 1000ML
• 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; 15 hampshire st; a la p, la mesa; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5690897
• MDR Text Key: 47325558
• Report Number: 1282497-2016-00280
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

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: Health Professional
• Device Model Number: 674669
• Device Catalogue Number: 674669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1