MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87216

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

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Diarrhea (1811); Dyspnea (1816); Fever (1858); Nausea (1970); Peritonitis (2252)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed to identify a causal relationship between the patient's peritoneal dialysis (pd) treatment and the reported fever, nausea, vomiting, diarrhea, shortness of breath (sob), pleuritic chest pain and peritonitis which warranted hospitalization and antibiotic therapy.The specific etiology of the peritonitis is unknown, therefore causality cannot be determined.The etiology of the fever, nausea, vomiting, diarrhea, shortness of breath (sob) and pleuritic chest pains is unknown, therefore definitive causality cannot be determined.However, these event(s) can reasonably be considered possible byproducts of the underlying peritonitis event.The treatment data provided was assessed, and showed no indication the liberty select cycler caused or contributed to an overfill and/or iipv event.Nor is there any evidence the liberty select cycler malfunctioned and/or failed to perform as expected in relation to this event.Although a causal relationship cannot be confirmed, a temporal relationship between the patient's pd therapy and the reported peritonitis remains.Should additional new information be made available this clinical investigation will be reevaluated.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt), called technical services regarding drain complications, and reported they were recently hospitalized for fluid retention.During follow-up, the peritoneal dialysis registered nurse (pdrn) stated the patient was hospitalized for fluid overload.Reportedly the pdrn noted a weight gain of approximately 4.9 kg (58.9 kg) prior to the patient¿s hospitalization.The patient continued to perform pd therapy while hospitalized, and the additional fluid was likely removed utilizing a 4.25% dialysate solution.The pdrn reported the patient has recovered from the event of fluid overload and continues to perform pd therapy without issue.The discharge summary was received and revealed the patient presented to the emergency room (er) after experiencing fever, nausea, vomiting, diarrhea, shortness of breath (sob) and pleuritic chest pains for four days.The patient¿s vitals upon admission were stable; blood pressure (bp) = 121/83, temperature (t) = 37.4, heart rate (hr) = 95, respirations (rr) = 17, oxygen saturation (o2sat) = 100%.The patient was initially diagnosed with sepsis (without shock), and possible healthcare associated pneumonia; though these were ruled out via computed tomography (ct) scan and chest x-ray.The patient was initially started on vancomycin and zosyn (dosage, route, duration and frequency unknown); however the antibiotic was changed to intraperitoneal (ip) ancef (dosage, duration and frequency unknown) after peritoneal effluent cultures returned positive for gram positive-cocci (genus and species unknown) and the patient was diagnosed with peritonitis.The patient was discharged in stable condition to their outpatient dialysis unit, and was scheduled to complete the course of ancef with the assistance of the pdrn.It is unknown if any fresenius device(s) and/or product(s) were utilized during the hospitalization.There was no evidence or indication of fluid overload contained in the discharge summary.The nephrology consult confirmed the patient frequently requires a high dextrose solution during pd therapy, due to poor ultrafiltration rates; however the patient continued undergoing pd therapy utilizing their current outpatient prescription throughout the hospitalization.The patient was noted to have lower extremity edema, which resolved during the hospitalization.

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: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• 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: 7833634
• MDR Text Key: 118786215
• Report Number: 8030665-2018-01321
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• 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
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER; DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 54