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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
Model Number 284508
Device Problem Overfill (2404)
Patient Problems No Patient Involvement (2645); Not Applicable (3189)
Event Date 12/03/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: device 1 of 3. The complaint device was received and evaluated. Visually, the tube set does not reveal any anomalies. There was fluid in the tube set and near the filter indicating that the filter could have gotten wet during usage. If the filter is wet the pressure will not regulate in the tube set. No functional testing can be performed since the filter is wet. This complaint is confirmed. A root cause for the reported failure cannot be discerned. The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required. At this point in time, no further action is warranted. However, depuy 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. Device 2 of 3. The complaint device was received and evaluated. Visually, the tube set does not reveal any anomalies. There was fluid in the tube set and near the filter indicating that the filter could have gotten wet during usage. If the filter is wet the pressure will not regulate in the tube set. No functional testing can be performed since the filter is wet. This complaint is confirmed. A root cause for the reported failure cannot be discerned. The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required. At this point in time, no further action is warranted. However, depuy 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. Device 3 of 3. The complaint device was received and evaluated. Visually, the tube set does not reveal any anomalies. There was fluid in the tube set and near the filter indicating that the filter could have gotten wet during usage. If the filter is wet the pressure will not regulate in the tube set. No functional testing can be performed since the filter is wet. This complaint is confirmed. A root cause for the reported failure cannot be discerned. The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required. At this point in time, no further action is warranted. However, depuy 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. (b)(4).
 
Event Description
It was reported by affiliate via complaint submission tool that during an anterior cruciate ligament reconstruction surgery an inflow tubing fms vue 24pk was used and when the intermed tubeset schkvlve 24pk was connected to the patient, it started the full filling of the reservoir, the change of the entire system was made at the middle of the surgery and it stopped working and no more liquid came of the system. The procedure was completed using a replacement. No patient consequence and no surgical delay was reported. No additional information was provided. It was later reported by the affiliate that the reported event caused a 15 minute delay due to changing tubes and setting up a new pump. It was reported the case was completed by a readily available pump provided by another supplier.
 
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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 SARL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9667142
MDR Text Key208125538
Report Number1221934-2020-00469
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
Report Date 02/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/30/2021
Device Model Number284508
Device Catalogue Number284508
Device Lot Number6169
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2020
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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