MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ENTERAL INFUSION PUMP

Model Number INFKIT2

Device Problem Failure to Auto Stop (2938)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

This device was not returned to mmdg for evaluation.Because the pump was not returned an investigation was not possible.A dhr review was completed and found no non-conformances associated with the device.Because a rate and dose is being set while the pump is in use, the pump cannot overrun and pump air to the patient unless the user is not putting enough formula in the feeding set.The amount of formula being added to the set was not reported to mmdg.The bags also state on the label that they should only be used for 24 hours.This report is being filed because the event occurred while the device was in use by a pediatric patient.Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.

Event Description

The initial reporter stated that the pump continues to pump when the dose is done.They stated that the patient would be missing their night time feed because of the issue.Mmdg did follow up with the initial reporter, who stated that they don't know what if any supplementation method was used for the patients night time feeding and stated that there was a language barrier when speaking with the patients caretaker.(b)(4).

Manufacturer Narrative

This device was returned to mmdg for evaluation,however, an investigation was not possible.A dhr review was completed and found no non-conformances associated with the device.Because a rate and dose is being set while the pump is in use, the pump cannot overrun and pump air to the patient unless the user is not putting enough formula in the feeding set.The amount of formula being added to the set was not reported to mmdg.The bags also state on the label that they should only be used for 24 hours.This report is being filed because the event occurred while the device was in use by a pediatric patient.Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.The complainant originally reported this issue and included the incorrect serial number (b)(4).The complaint actually occurred with pump serial number (b)(4).The pump was sent back to mmdg, however, the complainant asked that the pump be returned to them without any work or repairs performed.Mmdg was unable to perform an investigation and returned the pump to the complainant without a certificate of conformance and with a letter that states the pump should not be used, due to the refusal of service.

Event Description

The initial reporter stated that the pump continues to pump when the dose is done.They stated that the patient would be missing their night time feed because of the issue.Mmdg did follow up with the initial reporter, who stated that they don't know what if any supplementation method was used for the patients night time feeding and stated that there was a language barrier when speaking with the patients caretaker.(b)(4).

• Brand Name: ENTERALITE INFINITY ENTERAL INFUSION PUMP
• Type of Device: ENTERAL INFUSION PUMP
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer Contact: kristin hardesty ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 7175078
• MDR Text Key: 96738698
• Report Number: 1722139-2018-00009
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: INFKIT2
• Device Catalogue Number: INFKIT2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 5 YR