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

Model Number INFKIT2

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to mmdg for evaluation.A dhr was performed and no non conformances were found.Because the device was not returned, mmdg has been unable to investigate or confirm the complaint.This report will be updated if the device is returned to mmdg.

Event Description

The initial reporter stated that the pump was not delivering accurately.They stated that it was under infusing.They stated that the pump was programmed to deliver 350 ml but that it only delivered 100 ml.Mmdg followed up with the initial reporter who stated that the patient did not have any adverse effects due to the complaint.(b)(4).

Event Description

The initial reporter stated that the pump was not delivering accurately.They stated that it was under infusing.They stated that the pump was programmed to deliver 350 ml but that it only delivered 100 ml.Mmdg followed up with the initial reporter who stated that the patient did not have any adverse effects due to the complaint.(b)(4).

Manufacturer Narrative

The device was returned to mmdg for evaluation.A dhr was performed and no non conformances were found.When the device was returned to mmdg for investigation, the pump did under infuse due to a damaged roller.However, the pump was still within the volumetric range that mmdg considers not reportable.Based on this information, no mdr would have been required.

• 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
• MDR Report Key: 10514710
• MDR Text Key: 206329457
• Report Number: 1722139-2020-00421
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• PMA/PMN Number: K031199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

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
• Device Operator: Other
• 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: 11/13/2020
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 29