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

Model Number	8888145059
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Chills (2191)
Date of Event	06/30/2021
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, the patient developed chills and fever 3 hours after the dialysis.The body temperature was 38.6 (degrees celsius) and blood pressure was 105/65mmhg, and the infection related to catheter blood flow was considered.It was said that dexamethasone 5mg was given intravenously, return of blood to the machine, draw blood culture, blood routine, crp (c reactive protein), saa (serum amyloid a) were done and 0.9% sodium chloride 100ml plus injection with cephalosporin sodium 1g micropump was injected for 4hours and the tube was sealed.It was then reported that the patient caused the catheter infection which had nothing to do with the catheter and they were not responsible for it.The patient¿s infection had been controlled and the current dialysis treatment was normal.

• 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
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12769256
• Report Number: 3009211636-2021-00311
• Device Sequence Number: 4254729
• Product Code: MSD
• UDI-Device Identifier: 10884521013346
• UDI-Public: 10884521013346
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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: 12/17/2024
• Device Model Number: 8888145059
• Device Catalogue Number: 8888145059
• Device Lot Number: 2000700102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/08/2021
• Date Device Manufactured: 02/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male