MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; PUMP,FEEDING,ENTRAFLO H20,LEASE

Catalog Number ENT199255L

Device Problem Inaccurate Delivery (2339)

Patient Problems Feeding Problem (1850); Weight Changes (2607)

Event Date 06/30/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, when using the feeding pump it was "dispensing wrong dosage for what it was set for".The customer reported the pump was running for "1 week" before the reported incident was identified.The customer reported the patient lost weight as a result of the reported incident.The customer reported a different device was available to be used.Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, when using the feeding pump it was "dispensing wrong dosage for what it was set for".

Manufacturer Narrative

Device available for evaluation, returned to manufacturer, date returned to manufacturer device evaluated by manufacturer.Type of investigation.

• Type of Device: PUMP,FEEDING,ENTRAFLO H20,LEASE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17410068
• MDR Text Key: 319920969
• Report Number: 1417592-2023-00319
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENT199255L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other