MAUDE Adverse Event Report: DEPUY MITEK LLC US IRRIGATION TUBESET 24PK; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Catalog Number 284504

Device Problems Excess Flow or Over-Infusion (1311); Increase in Pressure (1491)

Patient Problems Swelling (2091); Not Applicable (3189)

Event Date 07/18/2019

Event Type  Injury  

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.Udi: (b)(4), incomplete.The lot number is unknown.

Event Description

It was reported by the affiliate via email that the fms vue pump, which controls the pressure of the physiological solution inside the shoulder, did not correctly regulate the pressure inside the patient's shoulder, and thereby generating an inflammation in the joint capsule.While checking the fms fluid management system/inflow tubing (fms duo+ or fms solo), it was verified that it is not compatible with the connection, the correct inlet tube would be fms fluid management system inflow tubing (fms vue) for this reason it is estimated that the inflammation was generated in the patient.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device was received for evaluation.Visual inspection confirms that the tube set that was returned is for an fms duo pump.The complaint report indicates that they tried to connect it to an fms vue pump.The duo tube set has a luer lock connection to the pump and the fms vue tube set has a quick disconnect fitting for connecting to the pump.The duo tube set would not be able to connect to an fms vue pump.This complaint can be confirmed.Operator error is the probable root cause of this failure.Furthermore, no lot number was supplied which precludes conducting a manufacturing record evaluation review.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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 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.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report b5: updated event description provided for reporting.H6: depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report 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.

Event Description

Updated event description : it was reported by the affiliate via email that the fms vue pump, which controls the pressure of the physiological solution inside the shoulder, did not correctly regulate the pressure inside the patient's shoulder, and thereby generating an inflammation in the joint capsule.While checking the fms fluid management system/inflow tubing (fms duo+ or fms solo), it was verified that it is not compatible with the connection, the correct inlet tube would be fms fluid management system inflow tubing (fms vue) for this reason it is estimated that the inflammation was generated in the patient.There was a resulting surgical delay of 1 hour approximately.The procedure was completed by performing another surgical technique.Surgical intervention was planned.Inflammation was generated in the joint capsule of the patient.There were no alternatives readily available.

• Brand Name: IRRIGATION TUBESET 24PK
• Type of Device: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8903330
• MDR Text Key: 154727525
• Report Number: 1221934-2019-58030
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705017393
• UDI-Public: 10886705017393
• Combination Product (y/n): N
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 284504
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 10/10/2019
• Patient Sequence Number: 1