MAUDE Adverse Event Report: ICU MEDICAL, INC. ADD-ON SET; ADDON-SET

Model Number CH3033

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2016

Event Type  malfunction  

Manufacturer Narrative

Lot review: a review of lot# 3202211 showed that (b)(4) units were manufactured, tested, inspected and released in march 2016, citing no anomalies.

Event Description

Complaint received regarding one ch3033, 14" bifuse add-on set w/bag spike, spiros w/red cap and vented cap, lot# 3202211 (mfd.03/2016).Report states; hole found in the infusion tubing, the perforated area is located at the location of the clamp moved up.No serious patient consequences reported.

Manufacturer Narrative

Lot review: a review of lot# 3202211 showed that (b)(4) units were manufactured, tested, inspected and released in march 2016, citing no anomalies.Incoming visual: 10/5/2016 - received on 8/31/2016 one ch3033, 14" bifuse add-on set w/bag spike, spiros w/red cap and vented cap, reported lot# 3202211.One used baxter 100ml saline bag.Two small cuts were observed in the bag spike adapter of the ch3033.Functional testing: the ch3033 device was leak tested with water and leaks occurred from the nicks (holes) in the add-on tubing at gravity pressure (1.5 psig).Analysis summary: the reported product problem for a hole in the add-on tubing was confirmed.The problem did appear to be caused by the spike of a drip chamber during insertion into the tubing.

Event Description

Complaint received regarding one ch3033, 14" bifuse add-on set w/bag spike, spiros w/red cap and vented cap, lot# 3202211 (mfd.03/2016).Report states; hole found in the infusion tubing, the perforated area is located at the location of the clamp moved up.No serious patient consequences reported.

• Brand Name: ADD-ON SET
• Type of Device: ADDON-SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 5949213
• MDR Text Key: 54666541
• Report Number: 2025816-2016-00137
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

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: Nurse
• Device Expiration Date: 03/01/2021
• Device Model Number: CH3033
• Device Catalogue Number: CH3033
• Device Lot Number: 3202211
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1