MAUDE Adverse Event Report: COVIDIEN EPUMP 500ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number 772055

Device Problem Air/Gas in Device (4062)

Patient Problems Vomiting (2144); Constipation (3274)

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.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that her son experienced quite a bit of vomiting while using the enteral feeding set.There would be weeks where he would throw up at least once a day.This was a huge issue with him gaining weight as he receives all his daily nutrition through a g-tube.Additional information was received from the customer and stated that air was getting in the feeding tube line during feeds.They adjusted the feed rates, timing, volume, and formulas.His vomiting was unpredictable.The customer further stated her son had some bad constipation during this time as well.He was prescribed (b)(6) for the constipation.

• Brand Name: EPUMP 500ML PUMP SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11740522
• MDR Text Key: 248204450
• Report Number: 1282497-2021-10124
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521023925
• UDI-Public: 10884521023925
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 772055
• Device Catalogue Number: 772055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR