MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY CORE TRUMPT 5MMX32CM FOR 1OR 2BAG 10/BOX; CATHETER, PERITONEAL

Catalog Number CD8190

Device Problem Self-Activation or Keying (1557)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

Conmed (b)(4) reported on behalf of their customer that the device, cd8190, core trumpt 5mmx32cm was being used on (b)(6) 2021 during an unknown procedure when it was reported the suction was activated despite the button was not pushed.The procedure was completed with an alternate same device.There was no impact or injury to the patient.After further assessment it was found, there was no delay to the procedure.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.

Event Description

Conmed japan reported on behalf of their customer that the device, cd8190, core trumpt 5mmx32cm was being used on 13dec21 during an unknown procedure when it was reported the suction was activated despite the button was not pushed.The procedure was completed with an alternate same device.There was no impact or injury to the patient.After further assessment it was found, there was no delay to the procedure.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event of the device self-activating is unconfirmed.Received two cd8190 in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the devices were received with the tubing cut off.There are no other obvious signs of abnormalities or defects.A functional inspection could not be performed due to the missing tubing.A two-year lot history review could not be performed since a lot number was not provided.A review of the device history review could not be performed since a lot number was not provided.A two-year review of complaint history revealed there has been a total of 10 reports, regarding 30 devices, for this device family and failure mode.During this same time frame 703,810 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.00004.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: CORE TRUMPT 5MMX32CM FOR 1OR 2BAG 10/BOX
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13357340
• MDR Text Key: 284475450
• Report Number: 3007305485-2022-00005
• Device Sequence Number: 1
• Product Code: GBW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K926477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

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 Catalogue Number: CD8190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic