MAUDE Adverse Event Report: COVIDIEN UNKNOWN ENTERAL FEEDING SET; PUMP, INFUSION, ENTERAL

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2019

Event Type  malfunction  

Manufacturer Narrative

Because the product id and lot number are unknown, a unique identifier (udi) number could not be provided.Additional information has been requested but at this time, no further details can be provided by the customer.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 states that the patient was totally dependent for nourishment on her peg implant necessitated by a throat operation to remove cancerous tissue.The product identification number and lot number is unknown.The feed pump system intended for home-use, provided by valley view hospital, continually failed because of bubbles in the tubing.Every bubble had to be squeezed along the tubing and vented at a hand-controlled valve located just prior to the entrance to the patient's stomach, that continued for 59 days.There was no training or guidance, apart from the printed instructions.Additional information provided by the patient's husband on (b)(6) 2021, stated that all medications had to pass through the peg system because the patient had become incapable of swallowing.The patient had her cancerous right salivary gland surgically removed by a specialist.She later underwent 33 radiation sessions with negligible chemotherapy.After the radiation was over she could barely walk or stand, hardly hear or talk, could discern only two letters on an eye chart and was fed solely via a peg.Over a half dozen mris and cts had shown that she was cancer free.She died two months after undergoing the last radiation session.

• Brand Name: UNKNOWN ENTERAL FEEDING 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 ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12018377
• MDR Text Key: 256774973
• Report Number: 1282497-2021-10293
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death