MAUDE Adverse Event Report: MAQUET GMBH MAQUET UNIVERSAL FRAME; ACCESSORIES, OPERATING-ROOM, TABLE

Model Number 1007.24A0

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 03/20/2015

Event Type  Death  

Event Description

After completion of a lumbar spine surgery (duration of the product about 5 hours), in prone position using the maquet universal frame 1007.24a0 together with the adjustable positioning elements 1007.28a0 - when the pt was transferred onto another operating room table top, electromechanical dissociation (emd) has been diagnosed.Resuscitation has been performed without success.The physician has reported that the event may hav e been caused by a pulmonary embolism.Manufacturer reference #2015-42432.

Manufacturer Narrative

The chief physician reported the alleged incident to maquet.The physician did not state that the device failed, or that the device contributed to the incident.The physician informed maquet that they will suspend the use of the adjustable positioning elements 1007.28a0 on the universal frame 1007.24a0.The event is under investigation by maquet.A follow-up report will be submitted once additional info is available.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Manufacturer Narrative

Many different parameters contribute to thrombosis and to thromboembolic events.For example the following parameters are known to have an influence on thromboembolic events in general: duration of the surgical procedure; patient disease; health status of the patient (concomitant morbidity); patient positioning in general (supine position against prone position); weight and age of the patient; prophylactic antithrombotic measures (e.G.Medication, surgical stocking).Thromboembolic events are known to occur in all kinds of surgery without one or several clearly identified risk factor(s).Therefore an informed consent without mentioning that such an event may occur is regarded to be incomplete.However, several tests with the affected adjustable positioning elements 1007.2bac were performed to determine whether also the device itself could have played a role.Measuring the venous backflow by doppler sonography, performed by two medical experts from outside, of different persons positioned on the adjustable positioning device revealed that the hip elements negatively affect the venous backflow under certain conditions and therefore may be considered as a contributing factor to thromboembolic events.

Event Description

(b)(4).

• Brand Name: MAQUET UNIVERSAL FRAME
• Type of Device: ACCESSORIES, OPERATING-ROOM, TABLE
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: bernd rokow ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321370
• MDR Report Key: 4787219
• MDR Text Key: 5813859
• Report Number: 8010652-2015-00007
• Device Sequence Number: 1
• Product Code: FWZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1007.24A0
• Device Catalogue Number: 1007.24A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 8010652-08/13/2015-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR