MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ENTERAL FEEDING PUMP; 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 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

The pump was returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.When the pump was returned to mmdg for investigation the pump had severe fluid ingress damage, which left the pcb board corroded and the pump unable to turn on.The complaint could not be invested because of this.

Event Description

The initial reporter stated that the pump was over infusing.They stated that the dose was set to 30 ml and that the pump was delivering about 50 ml.The initial reporter also advised that this had occurred during testing, and no patient was affected.(b)(4).

• Brand Name: ENTERALITE INFINITY ENTERAL FEEDING 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: 10847583
• MDR Text Key: 216766348
• Report Number: 1722139-2020-00599
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• 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: 11/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1