MAUDE Adverse Event Report: THE METRIX COMPANY SECURE AUTOCOMP6 XPS; HIGH SPEED COMPOUNDING DEVICE

Model Number 58810

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper Device Output (2953)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

The issue with the autocomp6 xps and the 663xx series of bags was initially identified thru internal testing.This was documented thru an internal corrective action report, (b)(4), which was initiated on 10/27/2014.The issue was not identified as a reportable event until the issue was reviewed during an fda inspection from 05/03/2016 thru 05/06/2016.All three compounding devices (secure autocomp6, autocomp6 xp and autocomp6 xps) will be recalled.Reference removal report number 1937141-05/26/16-001-r.Bags which may be used with the compounding devices, including the 663xx series of bags, are also being recalled.Reference removal report number 1937141-05/27/16-002-r.

Event Description

The empty eva containers, product number 663xx, were intended to be used as the final container with the secure autocomp6, autocomp6 xp or autocomp6 xps compounding devices for making parenteral nutrition solutions.When the empty eva containers were tested with the secure autocomp6 xps, the fill accuracy requirements were not met as defined in the secure autocomp6 xps user's manual.The required fill accuracy for volumes greater than or equal to 10 milliliters and up to 167 milliliters is plus or minus 5 milliliters per pump station.The required fill accuracy for volumes greater than or equal to 167 milliliters shall be within plus or minus 3% per pump station.Accuracy testing using a validated method has not been conducted with the secure autocomp6 or autocomp6 xp.As of (b)(6) 2016, no adverse events have been reported regarding this product problem.There are no potential adverse health consequences or hazardous situations to the user of the bag during the filling of the bag.The patient receiving the compounded bag may not receive the correct quantity of individual parenteral nutrition solutions or the correct overall quantity of parenteral nutrition solutions.Parenteral nutrition prescriptions may be standard or individualized based on the patient's condition, including addition of electrolytes.Adverse events related to incorrect overall quantity (too much or too little) could occur if the volume error involved electrolyte solutions, particularly potassium chloride, calcium chloride and magnesium chloride.Adverse events could include life-threatening cardiac arrhythmias, potentially resulting in serious injury or death.Inaccurate quantities with smaller volumes would be more critical, especially if the parenteral solution is intended for a pediatric patient.The consequences will be isolated to the patient who receives the parenteral nutrition solution.Health care professionals may have difficulty determining the source of potential adverse events resulting from incorrect quantity of solution delivered due to the complicated clinical condition of the patients receiving parenteral nutrition.

• Brand Name: SECURE AUTOCOMP6 XPS
• Type of Device: HIGH SPEED COMPOUNDING DEVICE
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• Manufacturer Contact: jennifer clasen ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 5690830
• MDR Text Key: 47340491
• Report Number: 1937141-2016-00001
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Pharmacist
• Device Model Number: 58810
• Device Catalogue Number: 58810
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1937141-05/26/16-001-R
• Patient Sequence Number: 1