MAUDE Adverse Event Report: ICU MEDICAL, INC. 9" SMALLBORE QUADFUSE EXT. SET

Model Number A1067

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#2892210 showed that (b)(4) units were manufactured, tested, inspected and released in july 2014, citing no anomalies.Receiving inspection: 09/06/2016 - received one new a1067, 9" smallbore quadfuse ext.Set.Lot# 2892210 and one used a1067, 9" smallbore quadfuse ext.Set.Unknown.No mating devices were returned.The device was not decontaminated.Functional testing:one new and one used a1067 quadfuse extension sets were returned for investigation of leakage.The two a1067 quadfuse extension sets were pressure leak tested.The used a1067 had leakage at two of the bonds between the wingless female luer and the male luer of the nanoclave.There was no leakage at any location along the fluid path of the new a1067 quadfuse extension set.Final analysis summary: the complaint of a1067 quadfuse leakage was confirmed with the used set.The leakage was the result of channel leakage between the wingless female luer and the male luer of the nanoclave due to an insufficient bond.The new a1067 quadfuse did not leak at any location along the fluid path.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 a1067, 9" smallbore quadfuse ext.Set, lot number unknown.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 number changed but the a1063 is a new problem.Delay in critical therapy reported.No adverse patient consequences reported.

• Brand Name: 9" SMALLBORE QUADFUSE EXT. SET
• Type of Device: 9" SMALLBORE QUADFUSE 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: 5962903
• MDR Text Key: 55125203
• Report Number: 2025816-2016-00134
• 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

• 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: A1067
• Device Catalogue Number: A1067
• Device Lot Number: SUSPECT LOT# 2892210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/20/2016
• 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