MAUDE Adverse Event Report: COVIDIEN EPUMP 1000ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number	773656
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
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 feed and bag hung to infuse until morning and the mom noticed that the feeds was backing up and during investigating, it was noted that the formula leaking from the pump.The customer further stated that the tubing broke.There was no patient harm reported.
Additional Manufacturer Narrative
The customer reported that the feed and bag were hung to infuse until morning.The feed was observed to be backing up, and when investigated further, the feed was found leaking from the pump.No patient injury/harm reported.This report refers to product code 773656, epump dehp feed 1000 ml, with lot number 201391142.A device history record (dhr) was unable to be performed as the lot number reported was invalid.A trend analysis of the reported failure mode did not identify a related trend.Additionally the dimensions of the tubing and mistic connector was review and all were verified to be within specification.One sample was returned for evaluation.Visual inspection confirmed the report of detached component as the device was received detached at the mistic connection.In order to perform functional testing, the device was reconnected by attaching the tubing to the misic connector and connecting the set to the pump.Functional testing completed found the device primed according to specification noting no fault was found.The following process controls are in place for the prevention and potential mitigation of risk: for every 8 assembled products 1 is inspected with go no go fixture.Quality inspection results for tensile test at the silicon tubing-mistic connector junction were reviewed and all of 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.At this time, additional action and/or corrective action is not required.This complaint will be closed and will be used for tracking and trending purposes.

• Brand Name: EPUMP 1000ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11406398
• Report Number: 1282497-2021-09949
• Device Sequence Number: 4568158
• Product Code: LZH
• UDI-Device Identifier: 10884521022096
• UDI-Public: 10884521022096
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/24/2021

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: 773656
• Device Catalogue Number: 773656
• Device Lot Number: 201391142
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 05/24/2021
• Patient Sequence Number: 1