MAUDE Adverse Event Report: ICU MEDICAL, INC. 4" SMALLBORE EXT. SET

Model Number A1063

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

Suspect lot review: a review of suspect lot#2892208 showed that (b)(4) units were manufactured, tested, inspected and released in july 2014, citing no anomalies.Receiving inspection: 9/6/2016 - received the following: two used a1063, 4" smallbore ext.Set.Reported lot# 2892208.Two new a1063, 4" smallbore ext.Set.Lot# 2892208.No mating devices were returned.The leak was confirmed at the threaded connection of the male luer of the nanoclave.Functional testing: two new and two used a1063 extension sets were returned for investigation of leakage.All four a1063 extension sets were pressure leak tested.The two used a1063 extension sets did exhibit leaking at the bond between the wingless female luer and the nanoclave male luer.The two new a1063 extension sets did not exhibit leakage at any location along the fluid path.Final analysis summary: the complaint of a1063 extension set leakage was confirmed with the two used sets returned.The leakage was the result of a channel leak between the wingless female luer and the male luer of the nanoclave due to an insufficient bond.The two new a1063 extension sets met pressure leak requirements outlined in the product performance specification.Additional investigation activities and engineering efforts are in progress to improve the bonding connection.As an interim measure heightened awareness have been initiated.

Event Description

Complaint received regarding three a1063, 4" smallbore ext.Set.Leaking noted around the nanoclave ports while infusing dopamine, occurred 3 times on one patient.Noticed as b/p failed to respond and fluid noticed to be leaking at the nanoclave.This was a problem in (b)(6) lot# changed but the a1063 is a new problem.Delay in critical therapy reported.No adverse patient consequences reported.

• Brand Name: 4" SMALLBORE EXT. SET
• Type of Device: 4" SMALLBORE EXT. 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: 5962911
• MDR Text Key: 55135681
• Report Number: 2025816-2016-00135
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2019
• Device Model Number: A1063
• Device Catalogue Number: A1063
• Device Lot Number: SUSPECT LOT# 2892208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• 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