MAUDE Adverse Event Report: OKLAHOMA CITY MANUFACTURING SITE HYST. FLUID MGMT SYSTEM CONTROL UNIT

Model Number 7210164

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Extubate (2402)

Event Date 05/27/2014

Event Type  Injury  

Event Description

During a hysteroscopic myomectomy utilizing a hysteroscopic fluid mgmt.System control unit, it was reported that the system alarmed.Prior to the alarm, the physician stated fluid levels were fine and the case was proceeding well.The patient¿s fluid deficit then jumped to 2000ml, the fluid management system alarmed, and fluid was noted on the floor by the smith & nephew sales representative that was present.The physician was advised of the maximum fluid deficit by the sales representative, as specified in the control unit user¿s manual.The doctor continued on with the procedure and once finished put the patient¿s legs down and was going to intubate the patient.However, the patient coded from fluid overload but was revived and brought to the i.C.U.Subsequently, the patient¿s condition was reported as fine and was extubated.

• Brand Name: HYST. FLUID MGMT SYSTEM CONTROL UNIT
• Type of Device: HYST. FLUID MGMT SYSTEM CONTROL UNIT
• Manufacturer (Section D): OKLAHOMA CITY MANUFACTURING SITE; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer (Section G): OKLAHOMA CITY MANUFACTURING SITE; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer Contact: robert bombard ; 150 minuteman road; andover, MA 01810 ; 9787491561
• MDR Report Key: 3900619
• MDR Text Key: 4542544
• Report Number: 1643264-2014-00011
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7210164
• Device Catalogue Number: 7210164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/27/2014
• Device Age: 20 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/29/2014
• Initial Date FDA Received: 06/27/2014
• Date Device Manufactured: 10/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention