MAUDE Adverse Event Report: ZEVEX INFINITY ORANGE FOOD PUMP

Model Number INFINITY ORANGE

Device Problem Failure to Deliver (2338)

Patient Problem Hypoglycemia (1912)

Event Date 08/23/2014

Event Type  Injury  

Event Description

Food pump (s/n (b)(4)) did not deliver formula or alarm.The baby became hypoglycemic as a result of no feedings for 7 hours.Mom said she filled the bag at 3 am and only puts in about 4 hours of formula at a time when she woke in the morning at 10, the bag was still full.She said that she could see formula moving back and forth in the tubing, but it wasn't flowing.They use neocate formula, wipe the food pump with a baby wipe when it's dirty to clean it.The pump is set at a rate of 38 ml/hr for continuous feeds, she said they usually set the dose at 330 as a back up because the pump has continued to pump air before when the bag is empty.The total volume delivered, according to the pump said 280.Food pump was exchanged out of the home.Re-education with mom was done on proper cleaning of the food pump, properly setting the dose so that it alarms appropriately, and mixing formula according to manufacturer recommendations.Mom stated that they had to do interventions throughout the day due to her being hypoglycemic and then becoming hyperglycemic after the intervention.She stated pt was sick all day, but did not require hospitalization or a doctor visit.

• Brand Name: INFINITY ORANGE FOOD PUMP
• Type of Device: FOOD PUMP
• Manufacturer (Section D): ZEVEX; salt lake city 84123
• MDR Report Key: 4048448
• MDR Text Key: 4730635
• Report Number: MW5037973
• Device Sequence Number: 1
• Product Code: LZH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: INFINITY ORANGE
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUCTION MACHINE IN THE HOME.; PATIENT ALSO HAS AN OXIMETER AND
• Patient Outcome(s): Other
• Patient Age: 1 YR