MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145040
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypovolemia (2243)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when patient had been on treatment for 20 minutes, leak occurred as a result of the disconnection of the venous lumen of the catheter from the bloodlines (different brand).The blood lines had been screwed into the luer ends of the catheter and the venous one had slipped off and not been physically unscrewed but arterial connection remained secured.After disconnection occurred, luer lock syringes were attached to both arterial and venous lumen and the venous though not easily noticed, appeared to have less thread.The patient had been had been on a competitor's machine (same brand as the bloodlines).There was no continuity or any issues with loose lines.Arterial pressures were on average between -100 and -140 and venous pressures between 80 and 120, pump speed 250-270 (all within the expected range for dialysis using a catheter).The catheter was not repaired and chlorhexidine 2% was used as the cleaning agent on the device.Tego was not utilized.There was nothing unusual noted on the device prior to use.It was mentioned that the patient has known hypersensitivities to dressings; tolerates a tegaderm chg.The patient had been advised several times not to use steroid creams, emollients or make up around the cvc (the patient had done this in the past several times).There was blood loss of approximately 500 ml.Initial treatment for hypovolemia following blood loss were saline bolus and stat dose of vancomycin was given.It was mentioned that after emergency care, the lumens were cleansed aseptically, flushed as per protocol, and the patient recommenced using new bloodlines (same brand as the previous one).Blood transfusion was required following repeat blood test two days later.Catheter was removed on (b)(6) 2021 and reinsertion of a new one was performed.Counselling for patient for the following weeks due to trauma and staff counselling was also performed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the patient's dialysis treatment, when patient had been on treatment for 20 minutes, leak occurred as a result of the disconnection of the venous lumen of the catheter from the bloodlines (different brand).The blood lines had been screwed into the luer ends of the catheter and the venous one had slipped off and not been physically unscrewed but arterial connection remained secured.After disconnection occurred, luer lock syringes were attached to both arterial and venous lumen and the venous though not easily noticed, appeared to have less thread.The patient had been on a competitor's machine (same brand as the bloodlines).There was no continuity or any issues with loose lines.Arterial pressures were on average between -100 and -140 and venous pressures between 80 and 120, pump speed 250-270 (all within the expected range for dialysis using a catheter).The catheter was not repaired and chlorhexidine 2% was used as the cleaning agent on the device and adapters.The cleaning agent was left to dry for 30 seconds as per recommendations.Tego was not utilized.The catheter was placed (x-ray used) and there was no documentation of solution used on insertion.It was mentioned that the patient has known hypersensitivities to dressings; tolerates a tegaderm chg.The patient had been advised several times not to use steroid creams, emollients or make up around the cvc (the patient had done this in the past several times).There was nothing unusual noted on the device prior to use and aside from the machine, bloodlines, and syringes, there were no other products being utilized with the device.There was blood loss of approximately 500 ml.Initial treatment for hypovolemia following blood loss were saline bolus and stat dose of vancomycin 1 gram intravenously (iv) was given via the dialysis circuit as a prophylactic measure because lines had been disconnected in a non-aseptic manner.There was no infection following the event.It was mentioned that after emergency care, the lumens were cleansed aseptically, flushed as per protocol, and the patient recommenced using new bloodlines (same brand as the previous one).The treatment was completed with the new lines.The patient was discharged home as planned (no extended stay) as per usual with instructions to go to the emergency if unwell which the patient did not need to do and the remaining dialysis was completed with no issues each event.It was mentioned that reasoning for new lines was that they had been possibly contaminated during non-aseptic detachment and there was an infection risk, but there were no issues with the actual lines or machines.The day after the event ((b)(6) 2020), the patient was lethargic and breathless at home but did not seek assistance.The patient returned to have dialysis as planned on (b)(6) 2020 and blood transfusion was required following repeat blood test.Haemoglobin was checked and was still 74 and the patient felt lethargic and breathless so one unit of blood was organised and given during her dialysis treatment that day.This went off with no issues and she was discharged home as planned at end of dialysis on the same day (no extended stay).Catheter was removed on (b)(6) 2021 and reinsertion of a new one was performed and had no issues with the new catheter.Counselling for patient for the following weeks due to trauma and staff counselling was also performed.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 11452706
• Report Number: 3009211636-2021-00059
• Device Sequence Number: 11643713
• Product Code: MSD
• UDI-Device Identifier: 10884521056664
• UDI-Public: 10884521056664
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 8888145040
• Device Catalogue Number: 8888145040
• Device Lot Number: 1908400321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR