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

Model Number	8888145058
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Chills (2191)
Date of Event	09/23/2021
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 reporter, after getting off the machine, the patient complained of chills and fever.The body temperature was measured at 37.3, the blood pressure was 120/70mmhg, and they considered the catheter blood flow related diseases.It was reported that the following preliminary action was done, blood culture, blood routine, crp(c-reactive protein test), saa (serum amyloid a), 0.9% sodium chloride 100ml, amoxicillin and clavulanate potassium 1.2g for injection, micro pump injection for 4 hours and the tube was sealed.Then it was found that the patient caused the catheter infection and had nothing to do with the catheter.It was also stated that it was verified on the tracker sales record that this model was not sold at this hospital.The patient infection has been controlled and the current dialysis treatment is 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: 12759123
• Report Number: 3009211636-2021-00309
• Device Sequence Number: 3133517
• Product Code: MSD
• UDI-Device Identifier: 10884521013339
• UDI-Public: 10884521013339
• 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): 11/05/2021

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: 03/08/2022
• Device Model Number: 8888145058
• Device Catalogue Number: 8888145058
• Device Lot Number: 1709500154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/07/2021
• Date Device Manufactured: 04/08/2017
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Female