MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP INFINITY ORANGE; PUMP, INFUSION, ENTERAL

Catalog Number MOOG'S ZEVEX INFINITY ORANGE

Device Problems Application Program Problem: Dose Calculation Error (1189); Inappropriate or Unexpected Reset (2959)

Patient Problem Vomiting (2144)

Event Date 09/21/2014

Event Type  malfunction  

Event Description

The patient was receiving intermittent tube feedings via nasogastric (ng) tube.After the infusion had started, the rate of the infusion was ordered to be increased, however the dose ordered (63 ml) did not change.When the rate was changed in the pump, the volume of the dose infused up to that point was not retained, but automatically reset to zero.The nurse (rn) was unaware of the dose reset and the infusion continued.The patient vomited and when the rn looked at the total volume infused (75 ml) she realized the total dose infused was more than what was ordered.She did not realize that with this pump she would have been required to subtract the volume already infused from the total dose to be delivered and entered that into the pump.The pump programming does not allow the rn to change the rate without defaulting the dose to zero.Most other infusion pumps are designed to let the infusion rate be changed independently of the dose.If tube feeding rates are being titrated based on patient tolerance this ability would be important.We would recommend that the manufacturer change the pump programming to facilitate changes to infusion rates without changing the dose, or require the rn to re-validate the dose volume left to be infused when the rate is changed.Manufacturer response: the rns will need to subtract the total given from the total intended dose and reset the dose, if the rate is changed during the infusion.

• Brand Name: INFINITY ORANGE
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 10805 rancho bernardo rd; san diego CA 92127
• MDR Report Key: 4529867
• MDR Text Key: 5541636
• Report Number: 4529867
• Device Sequence Number: 1
• Product Code: LZH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: MOOG'S ZEVEX INFINITY ORANGE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 MO
• Patient Weight: 7