MAUDE Adverse Event Report: ICU MEDICAL, INC. SPINNING SPIROS CONNECTOR

Model Number CH2000S

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

Int'l.((b)(6)) complaint received reporting particulate concerns during chemo preparations with use of ch2000s spinning spiros connector.It was reported that "staff discovered a foreign matter inside the spinning spiros housing when pulling out the reconstituted bortezomib of vial into the syringe.Production of these pharmaceuticals are performed aseptically in classified clean rooms and under laf.Pharmaceuticals are reconstituted with water for injection then pulled into syringe, already mounted spinning spiros and needle.Reconstituted pharmaceutical are visually inspected before pulling into syringe." there were no reported adverse consequences.Visual evaluation of the digital photograph that was provided does show a mark/particulate within the spiros connector.The photograph however was inconclusive in identifying the source/origin or root cause.Device return: one used ch2000s spinning spiros; one bd 1ml syringe and terumo neolus 18g were returned.

Manufacturer Narrative

Device investigation in progress.Initial findings: engineering evaluation is progress.At this time the cause of the reported product issue is unknown.

Manufacturer Narrative

Visual inspection of the returned used ch2000s recorded that there was a small piece of foreign material in the poppet.The particulate was removed and measured tappi size estimation chart tappi t 564: 0.6mm^2.Method (other) - the particulate was submitted to a lab for fourier transform infrared spectroscopy.(ftir) analysis.The ftir scan was inconclusive and was unable to confirm the particulate matter matched any of the materials used in the spiros connector.The source of the foreign matter was unable to be determined.Findings: testing and analysis of the returned ch2000s did confirm the presence of particulate matter.The origin/source and material properties of the particulate could not be determined.

Event Description

Additional information: device return: one used ch2000s spinning spiros: one bd 3ml syringe and terumo neolus 18g were returned.This is the manufacturer's follow up report to provide the return device investigation results.

• Brand Name: SPINNING SPIROS CONNECTOR
• Type of Device: SPINNING SPIROS CONNECTOR
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 4886631
• MDR Text Key: 6047884
• Report Number: 2025816-2015-00071
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor,company repres
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: CH2000S
• Device Catalogue Number: CH2000S
• Device Lot Number: 2932746
• Other Device ID Number: PR# 30255
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TERUMO NEOLUS 18G