MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY FEEDING PUMP; INFUSION PUMP, ENTERNAL EXTERNAL

Model Number NFP01

Device Problems Fail-Safe Design Failure (1222); Insufficient Flow or Under Infusion (2182)

Patient Problem Hypoglycemia (1912)

Event Date 10/09/2014

Event Type  Injury  

Event Description

Received a complaint call stating that the pump did not alarm when the tubing became kinked or clogged overnight.The pump just continued running (attempting to pump).The pt did not receive her overnight tube feeding, and her blood sugar was "critically low", according to her mother.The mother provided additional treatment to the child herself, in the form of apple juice and increased blood sugar monitoring, and the child recovered by mid-day.No other medical intervention was needed or performed.The family's nurse "duplicate" the situation, running the pump while holding the tube kinked.The pump did not stop or alarm.

Manufacturer Narrative

Moog reviewed the device's manufacturing history.No non-conformances were issued during its manufacture.Because the device was not returned for evaluation.Moog is unable to investigate further, and the claim remains unverified.

• Brand Name: ENTERALITE INFINITY FEEDING PUMP
• Type of Device: INFUSION PUMP, ENTERNAL EXTERNAL
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; salt lake city UT
• Manufacturer Contact: matt brinkerhoff ; 4314 zevex park ln.; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 4273107
• MDR Text Key: 5027876
• Report Number: 1722139-2014-00151
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NFP01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LIQUID HOPE
• Patient Outcome(s): Life Threatening
• Patient Age: 5.5 YR
• Patient Weight: 19