Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL TRANSPAC IV MONITORING KIT; TRANSDUCER MONITORING KIT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ICU MEDICAL TRANSPAC IV MONITORING KIT; TRANSDUCER MONITORING KIT Back to Search Results
Model Number 42648-06
Device Problems Disconnection (1171); Connection Problem (2900)
Patient Problem Chemical Exposure (2570)
Event Date 07/29/2017
Event Type  malfunction  
Manufacturer Narrative
Device was returned.Visual inspection: the as-received 42648-06 set was primed.The safeset reservoir tubing was found to be disconnected from the pressure tubing.The bonded connection was examined under a microscope and an incomplete solvent ring was found around the tubing connection.Function inspection: the other end of the device was pull tested per the product specification and the tubing met product performance specification.Analysis summary: the reported problem of tubing detachment was confirmed as insufficient solvent.A two year review of complaints database revealed one additional report for 42648-06/similar problem.
 
Event Description
Safeset reservoir was being pulled back to draw blood.While the reservoir was being drawn back, the tubing connected to the blood sampling port detached.This gave an open area where blood was run out freely from the arterial line.The tubing was quickly reattached, and then changed out completely.No adverse patient consequences were reported.
 
Manufacturer Narrative
Device was returned.Visual inspection: the as-received 42648-06 set was primed.The safeset reservoir tubing was found to be disconnected from the pressure tubing.The bonded connection was examined under a microscope and an incomplete solvent ring was found around the tubing connection.Function inspection: the other end of the device was pull tested per the product specification and the tubing met product performance specification.Analysis summary: the reported problem of tubing detachment was confirmed as insufficient solvent.A two year review of complaints database revealed one additional report for 42648-06/similar problem.
 
Event Description
The user facility reports on a medsun report (b)(4) that safeset reservoir was being pulled back to draw blood.While the reservoir was being drawn back, the tubing which is connected to the blood sampling port detached.Blood leaked freely from the arterial line.The tubing was quickly reattached, and then changed out completely.No adverse patient consequences were reported.The device was returned and visual examination confirmed the complaint of tubing separating from the sample port.The bonded connection was examined and found to have an incomplete solvent ring around the tubing.The reported product problem for tubing detachment was confirmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRANSPAC IV MONITORING KIT
Type of Device
TRANSDUCER MONITORING KIT
Manufacturer (Section D)
ICU MEDICAL
4455 atherton drive
salt lake city UT 84117
Manufacturer (Section G)
ICU MEDICAL
4455 atherton drive
salt lake city UT 84117
Manufacturer Contact
holly imes
4455 atherton drive
salt lake city, UT 84117
8012641747
MDR Report Key6857019
MDR Text Key85910252
Report Number2025816-2017-00206
Device Sequence Number1
Product Code KRA
UDI-Device Identifier00840619077365
UDI-Public840619077365
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070979
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number42648-06
Device Catalogue Number42648-06
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/28/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-