MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 050-87212

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Peritonitis (2252); Malaise (2359)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between ccpd and/or capd therapies utilizing the liberty cycler set and/or manual pd solutions and the adverse event of peritonitis.It is well established pd patients are at high risk for infections of the peritoneum.The patient¿s peritonitis can be directly attributed to a non-adherence to infection control procedures as reported by a medical professional.Non-adherence to aseptic technique or ¿touch contamination¿ is the leading source of the transmission of peritonitis causing pathogens.Though the effluent fluid culture presented no growth, it is well-known patients with previous antibiotic therapy may present negative culture results.In this case, the patient was previously on antibiotic therapy for prior peritonitis infections and evidence of this additional infection was based on the elevated wbc count.Therefore, the liberty cycler set can be excluded as the root cause of this infection.Based on the required information, there was no allegation or objective evidence any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a peritoneal dialysis (pd) patient had peritonitis.Upon follow up, the patient¿s pd registered nurse (pdrn) reported this patient presented to the outpatient clinic with cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the outpatient clinic on (b)(6) 2021 presented no growth and an elevated white blood cell (wbc) count (exact count unknown).The patient was diagnosed with peritonitis, and it was unknown if this event occurred with either ccpd or continuous ambulatory pd (capd) using manual solutions.The patient was prescribed intraperitoneal (ip) vancomycin and ip ceftazidime (unknown dosages, frequencies and durations).The patient developed general malaise despite antibiotic therapy.As a result, the patient was hospitalized on (b)(6) 2021 due to the persistent peritonitis infection.The patient was treated with antibiotics (unknown types, routes, dosages, frequencies and durations) and had the pd catheter (not a fresenius product) removed.The patient was transitioned to hemodialysis and subsequently discharged on (b)(6) 2021.It was confirmed the patient¿s peritonitis and the associated hospitalization were not related to any [fresenius] product issues but rather patient non-adherence to infection control procedures.

Event Description

It was reported that a peritoneal dialysis (pd) patient had peritonitis.Upon follow up, the patient¿s pd registered nurse (pdrn) reported this patient presented to the outpatient clinic with cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the outpatient clinic on (b)(6) 2021 presented no growth and an elevated white blood cell (wbc) count (exact count unknown).The patient was diagnosed with peritonitis, and it was unknown if this event occurred with either ccpd or continuous ambulatory pd (capd) using manual solutions.The patient was prescribed intraperitoneal (ip) vancomycin and ip ceftazidime (unknown dosages, frequencies and durations).The patient developed general malaise despite antibiotic therapy.As a result, the patient was hospitalized on (b)(6) 2021 due to the persistent peritonitis infection.The patient was treated with antibiotics (unknown types, routes, dosages, frequencies and durations) and had the pd catheter (not a fresenius product) removed.The patient was transitioned to hemodialysis and subsequently discharged on (b)(6) 2021.It was confirmed the patient¿s peritonitis and the associated hospitalization were not related to any [fresenius] product issues but rather patient non-adherence to infection control procedures.

Manufacturer Narrative

Correction: e1, e2, e3.

Event Description

It was reported that a peritoneal dialysis (pd) patient had peritonitis.Upon follow up, the patient¿s pd registered nurse (pdrn) reported this patient presented to the outpatient clinic with cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the outpatient clinic on (b)(6) 2021 presented no growth and an elevated white blood cell (wbc) count (exact count unknown).The patient was diagnosed with peritonitis, and it was unknown if this event occurred with either ccpd or continuous ambulatory pd (capd) using manual solutions.The patient was prescribed intraperitoneal (ip) vancomycin and ip ceftazidime (unknown dosages, frequencies and durations).The patient developed general malaise despite antibiotic therapy.As a result, the patient was hospitalized on (b)(6) 2021 due to the persistent peritonitis infection.The patient was treated with antibiotics (unknown types, routes, dosages, frequencies and durations) and had the pd catheter (not a fresenius product) removed.The patient was transitioned to hemodialysis and subsequently discharged on 4/jul/2021.It was confirmed the patient¿s peritonitis and the associated hospitalization were not related to any [fresenius] product issues but rather patient non-adherence to infection control procedures.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: FMC CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 12217598
• MDR Text Key: 263198426
• Report Number: 8030665-2021-01191
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87212
• Device Catalogue Number: UNKNOWN- FMC CASSETTE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR