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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Peritonitis (2252)

Event Date 04/10/2021

Event Type  Injury  

Event Description

It was reported a patient experienced a ratio of having a infection at any time.Upon follow up, the patient's pd registered nurse reported this patient presented to the outpatient clinic with symptoms of abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the outpatient clinic presented with staphylococcus epidermidis and a white blood cell (wbc) count of 13, 750/mm3.The patient was diagnosed with peritonitis due to poor aseptic technique during ccpd therapy on the liberty select cycler at home.It was reported the patient has vision problems that directly contributed to poor aseptic technique during pd therapy.The patient was prescribed intraperitoneal (ip) vancomycin at 1750 mg every five days for two weeks and ip gentamicin at 40 mg every day for two weeks.Repeat wbc counts taken in the outpatient clinic on (b)(6) 2021 presented with 1451/mm3 and on (b)(6) 2021 presented with 127/mm3.The patient was hospitalized on (b)(6) 2021 due to persistent symptoms of abdominal pain from an unresolved peritonitis infection that originated from (b)(6) 2021.Laboratory results taken in the hospital were not reported to the outpatient clinic.The patient's pd catheter (not a fresenius product) was removed, and a central vascular catheter was placed (unknown date) as the patient was transitioned to hemodialysis (hd) on a hospital provided hd machine (unknown brand and model) during this admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2021.It was confirmed the patient's peritonitis and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event and continues hd therapy on an in-center basis with plans to return to ccpd on the same liberty select cycler at home.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: 17537026
• MDR Text Key: 321169622
• Report Number: MW5143908
• 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: 06/24/2021

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