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

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.

• Brand Name: INFLOW TUBING FMS VUE 24PK
• Type of Device: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; 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 Key: 9667142
• MDR Text Key: 208125538
• Report Number: 1221934-2020-00469
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705023066
• UDI-Public: 10886705023066
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2021
• Device Model Number: 284508
• Device Catalogue Number: 284508
• Device Lot Number: 6169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1