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

Model Number 46103-68

Device Problems Leak/Splash (1354); Failure to Reset (1532)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 03/13/2014

Event Type  malfunction  

Event Description

Complaint received reporting leakage/blood loss with use of 46103-68, safeset transpac iv monitoring kits.It was reported that the 46103-68 kits luer activated valve "continues to get stuck down or pushed down when accessed." device return: one used "partial" 46103-68 mtg kit segment w/luer activated valve component and one pkgd 46103-68 mtg kit same lot #2787482 were returned.Mfrs investigation: visual inspection (pre/post decontamination) was performed.The results records the returned used 46103-68 segment luer activated valve (lav) component was recessed/damaged.There were no visual abnormalities with the returned packaged 46103-68 mtg kit.Functional testing of the pkgd 46103-68 monitoring kit to the applicable product specifications was performed.Additional testing also conducted with multiple component activations.The results recorded no performance issues and or out of spec condition.

Manufacturer Narrative

Engineering analysis of these luer activated valve components have shown recessed or "stuck-down" position/leakage condition can potentially occur if the valve component is activated with a long luer or a luer with sharp edges at an angled entry.For optimal performance it is recommended to use connector devices that comply with iso 594-1 std and techniques that employ a rotational motion while connecting and disconnecting the mating device to the valve.Techniques should ensure that the central axis of the connector and valve are inline with each other when connecting and disconnecting and not at an angle.Manufacturing record review: a review of the mfg lot build database records for the reported lot # 2787482 (mfg ate 12/2013) shows 140 units were mfg tested, inspected and released.There were no exception documents generated during the lot build.Findings: visual analysis of the "as-received" used 46103-68 device components (damaged/recessed) confirms the reported product issue.Although the exact cause(s) of this component damage/condition iis unk at this time, previous investigations have identified usage conditions that can contribute to this type of component recessed condition.Engineering testing of the returned pkgd 46103-68 same lot sample recorded no performance issues and or out of spec conditions.The complaint investigation report/photographs were provided to the facility/contacts for their review/records.

• Brand Name: SAFESET TRANSPAC IV MONITORING KITS
• Type of Device: SAFESET TRANSPAC IV MONITORING KITS
• 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: 3821244
• MDR Text Key: 4392005
• Report Number: 2025816-2014-00048
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46103-68
• Device Catalogue Number: 46103-68
• Device Lot Number: 2787482
• Other Device ID Number: PR# 24470
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/13/2014
• Event Location: Hospital
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NO INFORMATION