MAUDE Adverse Event Report: ICU MEDICAL, INC. Y-CLAVE

Device Problems Air Leak (1008); Failure to Reset (1532); Failure to Infuse (2340); Device Issue (2379)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Respiratory Acidosis (2482)

Event Date 06/30/2014

Event Type  Death  

Event Description

Notification rec'd reporting a hospira mfg.(b)(4) ext.Set configured with a icu medical mfg.Component (b)(4) y-clave high pressure reportedly malfunctioned and may have contributed to the event reported on facility medwatch # (b)(4).The ufmw describes the event as follows "patient was undergoing an open heart surgery involving mitral and aortic valve replacement.The patient's surgery was completed and the staff were in the process of moving the patient from the operating room table to a hospital bed when she experienced low blood pressure.The patient had a right internal jugular iv access with a swan-ganz catheter.A twin-site extension set (32 inch) with 2 clave ports and option-lok was connected to the iv access with iv fluids connected running to gravity.The physician attempted to administer medications using this iv line when air was noted in approximately 6-8 inches in the iv tubing.In addition, the distal clave port's inner valve was noted to be protruding from the port which left the port in the open position and could not be used.The physician disconnected the twin site extension set from the swan-ganz and aspirated air directly from the swan-ganz."the patient decompensated, cpr was in progress and she was kept on the operating room table and required re-exploration.It is unclear as to how the inner valve of the port became protruded, the air was in the line and the role this played in the patient's decompensation." patient was placed back on bypass.After an unspecified length of time, the patient's blood pressure was able to restored to a stable level, patient was removed from bypass and moved to cardiac recovery unit.On (b)(6) 2014, patient expired.F/u info and return status of the involved (b)(4) ext.Set has been requested.

Manufacturer Narrative

Conclusion: finished device not manufactured by icu medical (reporting firm).Initial conclusion: at this time icu medical, mfger.Of the y-clave component configured in the hospira mfg.(b)(4) ext set is unable to confirm and or determine potential cause(s) of the reported event as it relates to the y-clave component.

• Brand Name: Y-CLAVE
• Type of Device: Y-CLAVE
• 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: 4071381
• MDR Text Key: 4857155
• Report Number: 2025816-2014-00107
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2014
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 62 YR