MAUDE Adverse Event Report: ICU MEDICAL, INC. 7" PRESSURE INFUSION EXT.W/REMV. MICROCLAVE

Model Number 12514-01

Device Problems Connection error (1116); Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2014

Event Type  malfunction  

Event Description

Complaint received reporting attachment/leakage concerns with use of one 12514-01 7" pressure infusion exit set q/microclave clear.It was reported that the "option lock on extension set 12514-01 was disconnecting from the catheter.The threading does not match up with threading on the option lock (resulting in) leakage."the facilities director of emergency svs reported this product issue resulted in ".Delay in care due to the iv catheter coming apart during contrast injections.When the catheter came apart.Only a portion of contrast was injected the study had to be rescheduled.The study is based on how fast the contrast is taken up and if there is already a small portion of contrast present they had to wait until is reabsorbed and do the test all over again, thus causing a delay in diagnosis and therefore a critical delay in care.".

Manufacturer Narrative

Device return: although requested, the involved devices were not returned for analysis and confirmation.Manufacturer's investigation; eval codes: method - a two year review of the complaint database for (b)(4)/similar issues did record add'l reports/investigations.A review of those device return investigations identified mixed findings including usage/errors; no defect found; unk.There were no findings that identified/verified a contributing mfg/design related non-conformance.Findings: the involved devices/set-ups were not returned for analysis and verification.The exact cause(s) of the reported product experiences/issues are unk.This report and the associated info have been entered in the manufacturers database for analysis and trending.

• Brand Name: 7" PRESSURE INFUSION EXT.W/REMV. MICROCLAVE
• Type of Device: PRESSURE INFUSION EXT
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton dr; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 3973114
• MDR Text Key: 4748470
• Report Number: 2025816-2014-00063
• Device Sequence Number: 1
• Product Code: FPA
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12514-01
• Device Catalogue Number: 12514-01
• Other Device ID Number: PR# 25035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• 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