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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL INFLOW TUBING FMS VUE 24PK SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

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MEDOS INTERNATIONAL SàRL INFLOW TUBING FMS VUE 24PK SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE Back to Search Results
Catalog Number 284508
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Not Applicable (3189)
Event Date 10/26/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Initial reporter phone number (b)(6). Udi:(b)(4).
 
Event Description
It was reported by the affiliate via cst that during a lumbar neural formation ablation procedure on (b)(6) 2019, the fms vue console is turned on and makes the respective connections of the hose of 1 day, the system is purged, it is verified that the reservoir does not exceed the water limit, connection is made with the patient's hose and operation begins. After two minutes it begins to lose pressure and uncontrollably fill the reservoir. Having to pause several times to avoid filling more than half. The pump is restarted, connections are made again and the system failure continues. The pump activates pre-filling uncontrollably exceeding the limit. The staff is forced to make a 1-day hose change for the inflow tubing fms vue 24pk. The proper connections are made and its operation is correct throughout the procedure. The procedure is delayed by 15 minutes due to the failure of the hose and the system. The hose is sent labeled in the container. No patient consequences reported.
 
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Brand NameINFLOW TUBING FMS VUE 24PK
Type of DeviceSURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9353440
MDR Text Key207547623
Report Number1221934-2019-59650
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K951843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/30/2020
Device Catalogue Number284508
Device Lot Number5833
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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