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

Model Number INFKIT2

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 03/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to mmdg for investigation.A dhr was completed and found no non-conformances.Because the device was not returned to mmdg the complaint could not be investigated or confirmed.This report will be updated if the device is returned to mmdg.

Event Description

The initial reporter stated that the pump was alarming no flow out.They stated that they massaged the tubing and in-line occluder and that the pump started to free flow.They stated that they removed the administration set, and placed it back in the pump and that it stopped free flowing.Mmdg did follow up with the initial reporter who stated that the patient was doing well and there had been no adverse events associated with the complaint.(b)(4).

• Brand Name: ENTERALITE INFINITY FEEDING PUMP
• Type of Device: ENTERAL INFUSION PUMP
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city, ut
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city, ut
• Manufacturer Contact: kristin hardesty ; 4314 zevex park lane; salt lake city, ut ; 2641001112
• MDR Report Key: 9957579
• MDR Text Key: 187556363
• Report Number: 1722139-2020-00127
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• 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?: No
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 YR