MAUDE Adverse Event Report: COVIDIEN EPUMP INTL 1000ML FD AND FLUSH; PUMP, INFUSION, ENTERAL

Model Number 673662

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2020

Event Type  malfunction  

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 Description

The customer reported the hospital purchased boxes of the dual bags in september and almost every day the tube dislodges from the connector.Additional information received stated when the tube detaches, the formula leaks from the set.There was no patient harm.

Manufacturer Narrative

Investigation summary: the customer reported the hospital purchased 10 boxes of dual bags in september and almost every day the tube dislodges from the connector.No patient harm reported.The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.As part of this review, the dimensions of the tubing and mistic connector were reviewed, and all were found to be in specification.Lot and failure mode trending was reviewed and no related trends were identified.Two (2) samples were returned for evaluation.Visual inspection confirmed the report of tubing detachment/disconnection as the silicone tubing was detached from the mistic connector.Functional testing performed required reattaching the tubing to the mistic connector.The set was then connected to a pump and priming was completed without issue.Current process controls require one (1) of every eight (8) manufactured products be inspected with go no go fixture.Quality inspection results for the tensile test at the silicon tubing-mistic connector junction were reviewed and all the samples were found inside specification.A potential root cause of the confirmed detachment at the mistic connector is possible user misuse.The ifu states when loading the feed set to ¿grasp black ring retainer and gently stretch tubing around rotor and insert retainer into right pocket¿.Corrective actions are not necessary at this time as the historical manufacturing review determined the product met specification.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP INTL 1000ML FD AND FLUSH
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11177279
• MDR Text Key: 227033993
• Report Number: 1282497-2021-09848
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521028197
• UDI-Public: 10884521028197
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 673662
• Device Catalogue Number: 673662
• Device Lot Number: 182500094
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1