MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. TESIO LT HEMODIALYSIS CATHETER

Model Number BFS-6E.

Device Problem Disconnection (1171)

Patient Problems Cardiac Arrest (1762); Death (1802); Blood Loss (2597)

Event Date 10/01/2020

Event Type  Death  

Manufacturer Narrative

An investigation has been initiated.Additional information regarding the incident and the device sample have been requested.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

Patient called ambulance just after 0800, because he woke up with significant blood loss from tdc line.Ambulance crew arrived to find patient with a gcs 15 with unrecordable bp - decision made to try and extricate in carry chair - as he sat up, patient lost consciousness and then went into cardiac arrest.Transfusion and resuscitation in the home.Bought into ed.Met by full team.Als, intubated in first five minutes.Significant acidosis, asystole during the whole resuscitation.Resus terminated at 1132 and death confirmed.Renal reg was informed of patient in ed in cardiac arrest.After the patient's death reg attended ed to inspect tesio line.Line was not handled but photos taken and uploaded onto epr.Line had become disconnected at extension set.Renal reg attended pm ((b)(6) 2020) to inspect the tesio and to be sure that all parts of the tesio were intact (especially the inner connector ring that secure the extension set to the line).All was intact and no signs of injury to line (eg cutting).

Manufacturer Narrative

The red and blue tesio catheters were returned for evaluation.Both catheters had the lock right adapter extensions correctly assembled onto the lumens with the compression rings and collars.The report stated, "line had become disconnected at extension set." this is not how the device was returned.It is unknown which extension disconnected.The device lot number was not provided therefore a review of the manufacturing/inspection records was not possible.The report indicated that pictures of the device were taken.Requests for these pictures were unsuccessful.We are unable to determine the cause or factors that may have contributed to this event.Per iso standard 10555-1 the extension to lumen joint has a force of break minimum of 3.37lbs.Sterile devices were tested during an investigation of a different complaint and the average force of break was 32.9 lbs, which far exceed the minimum requirements.The tesio insertion kit includes instructions for use for the catheter clamp sleeve, that would occlude the catheter lumen and prevent blood loss in the event that the extension separated from the lumen.The sleeve and clamp were not returned.It is unknown if they were properly installed when the catheter was implanted.The instructions for use (ifu) state: "place the provided line clamp and sleeve onto the catheter lumen.Close the clamp to prevent blood loss or air embolism.".

• Brand Name: TESIO LT HEMODIALYSIS CATHETER
• Type of Device: TESIO LT HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10655828
• MDR Text Key: 210632832
• Report Number: 2518902-2020-00044
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BFS-6E.
• Device Catalogue Number: BFS-6E.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death