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

Model Number 8888145015

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, the device had a leak/hole in the mid way part of the arterial lumen of the catheter which was being cleaned using 2% chlorhexidine solution.It was stated that the patient was successfully commenced on hemodialysis via catheter at approximately 1:00 pm.After 2 hours into the treatment, the hemodialysis machine began to alarm with high (negative) arterial pressure.It was apparent that there was a breach or fracture on the catheter as blood was slowly visibly dripping from the lumen.The doctor covering the renal unit was informed of the event.The patient¿s blood was returned via the venous lumen, with the clamp on the arterial lumen which was repositioned below the visible leak and closed.The catheterization laboratory was informed to send the catheter for culture.Blood cultures were taken by the dialysis staff from each lumen with negative results.It was reported th at the patient was for central venous catheter replacement, where he was taken to the hospital catheterization lab at approximately 4:00 pm on (b)(6) 2018.The patient was admitted to hospital overnight for observation and was discharged the following day without any further dialysis treatment performed until his next scheduled treatment.The patient observations including bp and pulse remained consistent in pre, during and post dialysis treatment which indicated that the patient was awake and alert all throughout according to the observation chart in the dialysis unit.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: jacqueline st. pierre ; 15 hampshire street; mansfield, MA 02048 ; 5084524938
• MDR Report Key: 7499994
• MDR Text Key: 107830038
• Report Number: 3009211636-2018-00141
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521013169
• UDI-Public: 20884521013169
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2022
• Device Model Number: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 1715800118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• Date Device Manufactured: 06/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 73