MAUDE Adverse Event Report: COVIDIEN EPUMP 500ML PUMP SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	772055
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the patient was on continuous feeding when the feeds were found to be leaking from a hole in the feeding bag tubing onto the patient's heater for trilogy machine and onto the floor.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was release accomplishing all quality standards.Five (5) samples were received for evaluation.Visual and functional evaluation was performed on all the returned samples and no leaking was found.Since the reported issue could not be confirmed, a root cause could not be determined.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: EPUMP 500ML PUMP SET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 9296287
• Report Number: 1282497-2019-08757
• Device Sequence Number: 2361058
• Product Code: KNT
• UDI-Device Identifier: 00763000175634
• UDI-Public: 00763000175634
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 772055
• Device Catalogue Number: 772055
• Device Lot Number: 191890072
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 03/04/2020
• Patient Sequence Number: 1