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

Catalog Number 284508

Device Problem Overfill (2404)

Patient Problem Not Applicable (3189)

Event Date 10/15/2019

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. Udi: (b)(4). The expiration date is unknown.

Event Description

It was reported by the sales rep via phone that during a shoulder arthroscopy procedure the fill chambers on two of the customer's fms fluid management system inflow tubings kept filling up. The sales rep stated that the issue is not with the pump. The procedure was completed with a third like device and a different pump with no patient harm but there was a three minute surgical delay to the case to change out the tubesets. The sales rep stated that both devices were discarded by the customer.

• 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 SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9317407
• MDR Text Key: 197763627
• Report Number: 1221934-2019-59506
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 284508
• Device Lot Number: 6572
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage