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 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to mmdg, and therefore mmdg could not perform an investigation.A dhr was completed and found no non-conformances.Based on the reported complaint, the user appears to be tampering with the device, resulting in free flow.This report will be updated if any additional information is made available.

Event Description

The initial reporter stated that the pump was alarming error codes 10 and 12.They also stated that the pump overfed the patient and "flowed into patient at a faster rate than programmed".They also stated that they had removed the in-line occluder from the administration set, which has the potential to cause free flow.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).

Manufacturer Narrative

The device was returned to mmdg for evaluation.A dhr was completed and found no non-conformances.During the investigation the pump could not be tested due to persistent error codes.The pump was found to have fluid ingress, which had damaged the pc board, causing the error codes.Because of the fluid ingress, mmdg could not test the pump or confirm the complaint.

Event Description

The initial reporter stated that the pump was alarming error codes 10 and 12.They also stated that the pump overfed the patient and "flowed into patient at a faster rate than programmed".They also stated that they had removed the in-line occluder from the administration set, which has the potential to cause free flow.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: 9727027
• MDR Text Key: 180835311
• Report Number: 1722139-2020-00051
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• 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: 02/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• 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: 4 YR