MAUDE Adverse Event Report: COVIDIEN EPUMP FEED AND 1000MLFLUSH SET; PUMP, INFUSION, ENTERAL

Model Number 773662

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2020

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. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that there was evidence of a leak when the enteral nutrition was started, the set had a rupture.The issue was discovered during priming.There was no patient involvement; therefore, no patient injury, medical intervention or adverse reactions were associated with this event.

Manufacturer Narrative

Additional information: h1, h2, h3, h4, h6.Investigation summary: the customer reported there was evidence of a leak discovered during priming when the enteral nutrition began.There was no patient involvement reported.The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Product lot and failure mode trending was reviewed and a trend was not identified for the reported lot number or device failure.The reported device was not returned for evaluation; however, photographs were provided by the customer.An evaluation of the provided photograph confirmed the reported issue of leak.The root cause of the confirmed product failure was determined to be related to the rf sealing machine/process.Corrective action to replace the rf sealing machine was initiated and has been completed.No further action is required at this time and this complaint will be used for trending purposes.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10736408
• MDR Text Key: 213178674
• Report Number: 1282497-2020-09569
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 30884521022106
• UDI-Public: 30884521022106
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 773662
• Device Catalogue Number: 773662
• Device Lot Number: 200550182
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Patient Sequence Number: 1