MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS DUO PUMP +; FLUID MANAGEMENT SYSTEM

Catalog Number 284580

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Extravasation (1842)

Event Type  Injury  

Event Description

The following issue was discovered via a published individual case report by the mitek safety officer: individual case reports (complications).Author: fowler et al (2010) usa.Reference: fowler j, owens bd.Abdominal compartment syndrome after hip arthroscopy.Arthroscopy.2010 jan;26(1):128-30.Address: brett d.Owens, m.D., orthopaedic surgery, keller army hospital, west point, ny 10996, u.S.A.E-mail: b.Owens@us.Army.Mil.Patients group: n/a.Patient characteristics: age: (b)(6).Gender: male.Index operation: hip: arthroscopic debridement of anterior and superior labrum and pincer-type lesion, psoas tenotomy through capsular window for the debridement.Devices: fms, duo.Time of complication: end of operation.Type of complication: abdominal compartment syndrome.Joint: hip.Device: fms, duo.Suture: - other devices: - signs and symptoms: distension of abdomen, migration of fluid along the iliopsoas muscle and iliac vessels.Elevated bladder pressure, increased inspiratory pressure, serosanguinous fluid with the abdominal cavity, retroperitoneum was distended and boggy, obvious fluid track along the iliopsoas muscle and iliac vessels on the right side.Tissue damage: - imaging studies: - reoperation (related/unrelated): exploratory laparotomy (1200 ml of serosanguinous fluid).Medical treatment: - f/u time: pod-3: staged closure of abdomen.Pod-6: discharged.Imaging studies: - objective outcomes: improvement of his hip impingement.Functional outcomes: asymptomatic at last follow-up.Subjective outcomes: abdominal complaints related to his incision and abdominal compartment syndrome.

Manufacturer Narrative

Our patient safety department discovered this published white paper detailing a historical event in which some mitek devices were implicated.We cannot confirm that this issue had been previously reported to mitek, so we are filing an adverse event report to document the experience described in the article.At this point in time, no further action is warranted.However, this file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.Also, mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: MITEK FMS DUO PUMP +
• Type of Device: FLUID MANAGEMENT SYSTEM
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: arthur frigault ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 3584232
• MDR Text Key: 4191247
• Report Number: 1221934-2014-00031
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/13/2014,01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2014
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR