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

Model Number 42586-05

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

Complaint received reporting "loose connections" and leakages with use of one 42586-05 transpac iv neonatal mtg.Kit.It was reported that ".Nurse had to retighten a loose connection to the distal port, next to the flush port after performing a blood draw on a new born." there were no reported adverse pt.Consequences.No additional information provided, lot number is unknown, 42586-05 monitoring kit was discarded.A 2013 - 2014 management quarterly reviews of in-process assembly/quality trend reports identified no contributing issues or adverse trends for the applicable components/sub assy builds used in this configuration.Findings: the involved 42586-05 device was not returned for analysis and confirmation.The directions for use does not instruct clinicians to "tighten all connections." the exact cause(s) of the reported event/product issue cannot be determined at this time.

Manufacturer Narrative

A review of the complaint database for 2012 - 2014 ytd for list number 42586-05/ similar product issue was performed.The results recorded no add'l reports or investigations identifying a mfg.Non-conformance.Note: unable to provide complete responses, facility reportedly submitted (b)(4) regarding this product issue/event.Although the mfr requested a copy of this (b)(4) report, as of the date of this mdr submission copy has not been provided.

• Brand Name: TRANSPAC IV NEONATAL MONITORING KIT
• Type of Device: TRANSPAC IV NEONATAL MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 3856675
• MDR Text Key: 4681585
• Report Number: 2025816-2014-00056
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42586-05
• Device Catalogue Number: 42586-05
• Other Device ID Number: PR # 24640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2014
• Event Location: Hospital
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1