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

Catalog Number UNKNOWN- FMC CASSETTE

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

Patient Problems Abdominal Pain (1685); Fatigue (1849); Fever (1858); Peritonitis (2252)

Event Date 06/20/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the adverse events of peritonitis, characterized by abdominal pain, fever and weakness.It is well established pd patients are at high risk for infections of the peritoneum.The patient¿s peritonitis can be directly attributed to touch contamination as reported by a medical professional.Touch contamination is the leading source of the transmission of peritonitis causing pathogens.Therefore, the liberty cycler set can be excluded as the root cause of this infection.Based on the available 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 has peritonitis.Upon follow up, the patient¿s pdrn reported this patient presented to the outpatient clinic with symptoms of fever, abdominal pain, weakness and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures presented with gram-positive microorganisms in chains (sensitivity not available) and a white blood cell (wbc) count of 4638/mm3.The patient was diagnosed with peritonitis with a probable cause of touch contamination during ccpd therapy on the liberty select cycler at home.The patient was not hospitalized for this event and prescribed intraperitoneal (ip) vancomycin at 2000 mg every 3 days for two weeks and ip ceftazidime at 2000 mg every day for two weeks.It was confirmed the patient¿s peritonitis, and the associated symptoms were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient is recovering from this event at home and continues ccpd therapy on the same liberty select cycler at home following this event.

Event Description

It was reported that a peritoneal dialysis (pd) patient has peritonitis.Upon follow up, the patient¿s pdrn reported this patient presented to the outpatient clinic with symptoms of fever, abdominal pain, weakness and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures presented with gram-positive microorganisms in chains (sensitivity not available) and a white blood cell (wbc) count of 4638/mm3.The patient was diagnosed with peritonitis with a probable cause of touch contamination during ccpd therapy on the liberty select cycler at home.The patient was not hospitalized for this event and prescribed intraperitoneal (ip) vancomycin at 2000 mg every 3 days for two weeks and ip ceftazidime at 2000 mg every day for two weeks.It was confirmed the patient¿s peritonitis, and the associated symptoms were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient is recovering from this event at home and continues ccpd therapy on the same liberty select cycler at home following this event.

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: 12079254
• MDR Text Key: 258870598
• Report Number: 8030665-2021-01074
• Device Sequence Number: 1
• Product Code: FKX
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN- FMC CASSETTE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 72