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

Model Number 7210164

Device Problem Pressure Problem (3012)

Patient Problem Hyperventilation (1910)

Event Date 04/17/2014

Event Type  Injury  

Event Description

During the case the patient was breathing heavily and was given albuterol.Final deficit 2490, max 2500.Additional information received from the sales rep.That was present during the procedure indicates the following: surgeon was not a first time user of the fluid mgmt.System.Surgeon noticed the fluid deficit was high, and sales rep.Made sure the surgeon was well aware of the high deficit and decided to stop right before 2500.Surgeon could not confirm the patient had received an embolism however she was trying to figure out what was wrong with the patient and trying to cross reference any potential issues.The patient did not experience any other symptoms other than the heavy breathing that was reported.The ct scan was taken after the procedure in the er.The doctor indicated the ct scan was clear of any air embolisms and the patient was admitted to the hospital for three days due to her vitals being very low.It is unknown if the patient was given any treatment other than albuterol for her breathing issue.Status of patient post discharge is believed to be good.The hysteroscopic morcellator ultra blade was also used during the procedure.There was flow through the outflow tube.The setting for suction was set at 300 on the regulator.

Manufacturer Narrative

The fluid management system will not be returned for analysis.(b)(4).

• Brand Name: GYN FLUID MGMT SYSTEM
• Type of Device: HYST. FLUID MGMT SYSTEM CONTROL UNIT
• Manufacturer (Section D): OKLAHOMA CITY MANUFACTURING SITE; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): OKLAHOMA CITY MANUFACTURING SITE; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: robert bombard ; 150 minuteman road; andover, MA 01810 ; 9787491561
• MDR Report Key: 3813698
• MDR Text Key: 4529531
• Report Number: 1643264-2014-00005
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/17/2014

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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2014
• Event Location: Ambulatory Surgical Facility
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/15/2014
• Date Device Manufactured: 03/11/2014
• 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
• Patient Age: 41 YR