MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC IV SAFESET RESRV. MONITORING KIT

Model Number 42644-06; 42648-06

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Devices returned: two (2) packaged 42648-06 from potential lot# 3465557; 353308; two (2) used partial segments from 42648-05 bag 2 and 42644-06 bag 1 monitoring kits.Qe investigation and analysis.Visual evaluation of the "as received" partial segments recorded the 42648-06 segments smallbore tubing was separated from the safeset port.Further analysis showed incomplete solvent ring around the diameter of the tubing; the 42644-06 segments one way stopcock slip-on luer wa broken off and stuck inside the female luer of the arterial tubing.The qe analysis found this breakage/damage was most likely due to excessive bending / force.The packaged devices were tested per the applicable product specifications.The results recorded no functional failures and or out of spec conditions.Additional pull testing was performed on the unused sets bonded connections.The results recorded the bonded component connections exceeded the specifications.

Event Description

Complaint received reporting component separation issues with unknown transpac iv monitoring kit list numbers.The initial information received reports during the week of (b)(6) there were five occurrences in the icu where "tubing disconnected at safeset sampling port".There were no reported adverse patient consequences.Additional relevant information although requested was not provided or available from the facility contact.The information, device identity as recorded on this report was obtained with receipt of the involved complaint units.

• Brand Name: TRANSPAC IV SAFESET RESRV. MONITORING KIT
• Type of Device: TRANSPAC IV SAFESET RESRV. MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 7242319
• MDR Text Key: 99198865
• Report Number: 2025816-2017-00234
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42644-06; 42648-06
• Device Catalogue Number: 42644-06; 42648-06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1