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 Unspecified Infection (1930); Malaise (2359)

Event Date 09/29/2019

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between pd therapy on the liberty select cycler with the fmc cassette and the patient event of not feeling well with subsequent hospitalization with possible infection.However, there is no documentation in the complaint file to show a causal relationship between the patient event and use of the liberty select cycler.Although it was not confirmed, all pd patients are at increased risk of infection due to a compromised immune system.There are several causes of infection in the peritoneal cavity other than pd including abscess, pancreatitis and diverticulitis.Based on the available information and no allegation of a malfunction, deficiency or defect, the liberty select cycler and fmc cassette can be excluded as the cause of the patient not feeling well with hospitalization and possible infection.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.

Event Description

This is a report of a peritoneal dialysis (pd) patient that was hospitalized on (b)(6) 2019 due to malaise.The hospitalization was reported during a follow up call with the patient's wife.Upon follow up with the pd registered nurse (pdrn) it was reported that the patient was hospitalized after they were unable to complete their treatment via manuals and weren't feeling good.Pdrn confirmed patient was still at the hospital as of (b)(6) 2019.The hospital found that the patient has an infection of the peritoneal cavity area and they were placed on intravenous treatment (treatment type unspecified).The pdrn refused to provide any further information because of confidentiality reasons but indicated that the issue has nothing to do with the use of the liberty select cycler.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 1100 e. military hwy., suite c; pharr TX 78577
• Manufacturer Contact: amaral, matthew ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9206049
• MDR Text Key: 162823923
• Report Number: 8030665-2019-01605
• 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: consumer,health professional
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• 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: 10/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention