MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM1200 DY DISPLAY (1200-DY)

Model Number 1200DY

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2015

Event Type  No Answer Provided  

Event Description

On (b)(6) 2015, the senior pharmacy technician at clinical specialties had contacted baxter technical services in (b)(4), colorado, to report a total of 6 bags that had completed delivery before the scheduled completion.The bags were pumped and infused to 6 patients.All patients are home care patients.The pharmacy had created a batch of total parenteral bags for each patient to bring home for the week.It was reported by the nurses that the infusion pumps used to infuse the bags started alarming.When the nurses checked why the infusion pumps were alarming, the nurses noticed the bags had run dry.In regards to patient status, the senior pharmacy technician indicated that the 6 patients are stable and doing fine.This report is for the (b)(6) year old, male, patient c; 3 of 6 reports from the same event as it involved 6 different patients.

Manufacturer Narrative

The evaluation of the data provided from the two em1200 compounders at clinical specialties showed no evidence that the em1200 compounder contributed to the bags prematurely running dry during infusion.The curlin pump instructions provided to patient c: 3 of the bags are to be infused at 2100ml iv three days per week (every monday, wednesday, friday) over 10 hours via curlin pump.2 of the bags are to be infused at 2100ml iv two days per week (every sunday and thursday) over 10 hours via curlin pump.The curlin infusion pumps used to infuse the bags in this event will be reported and reviewed by the manufacturer.Baxter healthcare is not the manufacturer of the curlin infusion pump.Method: - data validation order entry labels, compounder mixcheck reports and the black-box data were reviewed and evaluated.Results: user device interface, it is unknown how or what caused the nutrition bags to run dry.Conclusion: no failure detected, device operated within specification.The information from the data provided found that the em1200 compounder did not contribute to this event.Device not available for return.

• Brand Name: EM1200 DY DISPLAY (1200-DY)
• Type of Device: EM1200 DY DISPLAY (1200-DY)
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: phone vang ; 9540 s maroon circle; # 400; englewood, CO 80112 ; 3037846639
• MDR Report Key: 4594375
• MDR Text Key: 5628865
• Report Number: 1419106-2015-00033
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1200DY
• Device Catalogue Number: 1200DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR