MAUDE Adverse Event Report: ICU MEDICAL. INC. DIANA SYSTEM W/ WIRELESS SCANNER

Model Number CH5132

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

User facility/importer number - mw5059661.Date of this report - 01/15/2016.Report sent to fda - yes 01/15/2016.Report sent to manufacturer - yes 02/23/2016.Upon fda request, this report is being resubmitted electronically.

Event Description

Complaint received reporting dispensing volume irregularities with use of ch5132 diana systems w/ wireless scanner.The information reported describes the events as follows ".(facility) was creating an insulin infusion bag transferring 1 ml of insulin into 100ml of saline for three pediatric patients.After administering the medication to the patients and not seeing any change in patient status, the facility removed the insulin bags, remade them by hand and re-administered.After the patient care needs were addressed the initial bags were then analyzed" and the mixture / insulin dosage irregularity was detected.Subsequent potency testing of the patient sample bags and an unused bag further identified inconsistent potency values.Facility has discontinued the use of ch5132 in the production of insulin stock bags (for) used channel one in the process.Resume our manual doseedge process for insulin production.It was also reported that ".Customer is requesting to make the difference between operating range and accuracy range more prominent in the manual and discourage use under specified volumes.While no adverse outcomes have been reported, icu medical is notifying customers out of an abundance of caution.While the diana automated system user manual provides the system specification, the concern appears to be related to the misinterpretation of the operating range and accuracy specifications.Ch5132 reported serial number (b)(4).

• Brand Name: DIANA SYSTEM W/ WIRELESS SCANNER
• Type of Device: DIANA SYSTEM W/ WIRELESS SCANNER
• Manufacturer (Section D): ICU MEDICAL. INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton drive; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, IL 84123 ; 8012641400
• MDR Report Key: 5535447
• MDR Text Key: 226120288
• Report Number: 2025816-2016-00006
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH5132
• Device Catalogue Number: CH5132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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