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

Model Number 42597-05

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device return: one (1) used 42597-05 partial segment.Qe analysis: visual analysis of the "as-received" 42597-05 segment confirmed the high pressure proximal and distal tubing was separated from the bonded male luer connections.The returned affected components were analyzed.The qe report noted evidence of a full solvent ring at the correct bond depths.

Event Description

Complaint received reporting issues with five (5) transpac iv bifurcated mtg kits.The initial information received reports during the week of sept.5th there were five occurrences in the icu where "tubing disconnected from the luer below zeroing stopcock".There were no reported adverse patient consequences.

• Brand Name: TRANSPAC IV BIFURCATED MONITORING KIT
• Type of Device: TRANSPAC IV BIFURCATED 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: 7241554
• MDR Text Key: 99784975
• Report Number: 2025816-2017-00233
• 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: 11/02/2017

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 Model Number: 42597-05
• Device Catalogue Number: 42597-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1