MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Problems Microbial Contamination of Device (2303); Appropriate Term/Code Not Available (3191)

Patient Problems Renal Failure (2041); Sepsis (2067); Peritonitis (2252)

Event Date 03/01/2021

Event Type  Death  

Event Description

It was reported that a peritoneal dialysis (pd) patient passed away and had peritonitis at the time.Upon follow up, the patient's pd registered nurse (porn) reported this patient was hospitalized (admission date not reported) for peritonitis.Peritoneal effluent fluid cultures taken in the hospital on (b)(6) 2021 presented with escherichia coli, bacteroides fragilis and enterococcus spp.White blood cell (wbc) counts presented with 41,375/mm3 with neutrophils at 97%.The patient was diagnosed with peritonitis due to possible contamination during ccpd therapy on the liberty select cycler.The patient was prescribed the following medications in response to the infection: intravenous (iv) vancomycin at 1 gm with every dialysis treatment, iv cefepime at 1 gm with every dialysis treatment, intraperitoneal (ip) ceftazidime at 1 gm (unknown frequency or duration), iv daptomycin at 500mg (unknown frequency or duration), iv micafungin at 100 mg, iv piperacillin 3000 mg/tazobactam 375mg (unknown frequency or duration), one-time iv piperacillin 4000 mg/tazobactam 500 mg as a loading dose on (b)(6) 2021 and ip vancomycin at 500 mg (unknown frequency or duration).The patient was able to undergo ccpd therapy on a hospital provider cycler (unknown brand and model) during this admission until (b)(6) 2021 when the patient's pd catheter (not a fresenius product) was removed due to severe sepsis and peritonitis.The patient continued with hemodialysis (hd) for renal replacement therapy on a hospital provided hd machine (unknown brand and model) for the duration of the hospitalization.An additional wbc count was taken on (b)(6) 2021 to show the effectiveness of antibiotics, which presented 933/mm3 with neutrophils at 90%.The patient subsequently expired in the hospital on (b)(6) 2021 due to sepsis from bacterial peritonitis and end-stage renal disease (esrd).It was unknown if the patient was actively dialyzing on or around the time of his death.Additionally, it was unknown if the patient's death was related to pd therapy and/or any fresenius product(s) or device(s).The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PD CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17537066
• MDR Text Key: 321043155
• Report Number: MW5143947
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1