MAUDE Adverse Event Report: HOLOGIC AQUILEX FLUID CONTROL SYSTEM

Catalog Number AQL-100P

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Edema (1820); Abdominal Distention (2601)

Event Date 11/26/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the aquilex fluid control system.No relationship can be established between dhr and current complaint.(b)(4).

Event Description

It was reported that a physician attempted to perform a myosure procedure for uterine tissue removal utilizing the aquilex fluid control system on (b)(6) 2013.The pt exhibited facial edema and abdominal distention.The physician aborted the procedure as the aquilex pump was unable to determine the fluid deficit.The pt was admitted into the hospital."during the pt's hospital stay her vital signs were monitored.Nuro examinations were performed periodically though the night.Her electrolytes were also performed serially.Her potassium upon admission was 3.3.She was given 40 meq kcl (potassium) which did improve her hypokalemia.The pt was asymptomatic during her entire stay.She denied any chest pain or shortness of breath.She felt that her facial edema and the edema in her lower extremities improved overnight.Of note, she diuresed approximately 6250 ml spontaneously.The hospitalist service also evaluated the pt during her stay regarding her fluid retention and hypokalemia".The pt was discharge home on (b)(6) 2013.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan, manager ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 3652936
• MDR Text Key: 21273154
• Report Number: 1222780-2014-00023
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/23/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AQL-100P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/26/2013
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MYOSURE CONTROL UNIT: SERIAL NUMBER UNK; NUMBER UNK; MYOSURE DISPOSABLE TISSUE REMOVAL DEVICE: LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 83