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

Model Number 050-87216

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

Patient Problems Death (1802); Sepsis (2067); Weakness (2145); Peritonitis (2252); Obstruction/Occlusion (2422); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: there is a possible temporal relationship between pd therapy utilizing the liberty select cycler with cycler set and the patient event of hospitalization for confusion and weakness with subsequent diagnosis of bowel obstruction and ileus with unconfirmed peritonitis, but it is unknown if the patient was completing treatment at the time of the event.However, there is no documentation in the complaint file to show a causal relationship between the patient¿s adverse event and use of the liberty select cycler with cycler set.Additionally, there is no allegation of a device malfunction or deficiency or cycler set defect reported for this hospitalization.The patient was initially reported to have peritonitis.The pdrn did not have any report of peritonitis but did have a diagnosis of bowel obstruction and ileus.It is known that it is possible for peritonitis to develop from complications of an ileus if the bowel contents leak into the abdominal cavity.No documentation from the hospitalization was available for confirmation.Based on the available information and no allegation of malfunction, deficiency or defect, the liberty select cycler and cycler set can be excluded as the cause of the patient¿s hospitalization for bowel obstruction and ileus with unconfirmed peritonitis and transition to hemodialysis.

Event Description

A patient contact reported that a former peritoneal dialysis (pd) patient has peritonitis.It was reported that the patient has been in the hospital, and no longer utilizing pd therapy for months.No additional details were provided at intake.Upon follow-up, the peritoneal dialysis registered nurse (pdrn) stated that the patient was no longer an active pd patient at the clinic.The information that the pd clinic received was that approximately a month ago (date unknown) the patient was hospitalized for weakness and confusion.The patient was diagnosed with a bowel obstruction and ileus.The pdrn stated there was no report given to the clinic stating that the patient was diagnosed with peritonitis as reported by the patient contact.However, the pd clinic does not have any additional information related to the patient¿s hospitalization.The patient is not active in the clinic record system.The patient has been completing hemodialysis (hd) and plans to continue with in-center hd following discharge from the hospital.The patient could possibly return to pd therapy if they regain strength.No further information was available.

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.

Event Description

Additional information received: the patient contact reported that the patient expired on (b)(6) 2020 due to an infection from peritonitis.Additional follow-up was conducted with the peritoneal dialysis (pd) clinic manager.Information obtained from the patient¿s pd clinic stated that the patient was no longer an active pd patient at the clinic.The information that the pd clinic received was that approximately a month ago (date unknown) the patient was hospitalized for weakness and confusion.The patient was diagnosed with a bowel obstruction and ileus.The bowel obstruction and ileus subsequently led to a severe case of sepsis and eventual death of the patient.The patient had been undergoing in-center hemodialysis (hd) for over 30 days and was not diagnosed with peritonitis as reported by the patient¿s contact.The pd clinic does not have any additional information related to the patient¿s hospitalization.The patient is not active in the clinic record system.The pd clinic reported that the patient¿s adverse events were not related to any fresenius device(s), drug(s) and/or product(s).No further information was available.Updated clinical investigation: there is a possible temporal relationship between pd therapy utilizing the liberty select cycler with cycler set and the patient event of hospitalization for confusion and weakness with diagnosis of bowel obstruction and ileus with subsequent sepsis and death, but it is unknown if the patient was completing treatment at the time of the event.However, there is no documentation in the complaint file to show a causal relationship between the patient¿s adverse event and use of the liberty select cycler with cycler set.Additionally, there is no allegation of a device malfunction or deficiency or cycler set defect reported for this hospitalization.The patient¿s diagnosis of bowel obstruction and ileus with subsequent sepsis and death was reported to be unrelated to any fresenius device(s), drug(s) and/or product(s).Based on the available information and no allegation of malfunction, deficiency, or defect, the liberty select cycler and cycler set can be excluded as the cause of the patient¿s hospitalization for bowel obstruction and ileus with subsequent sepsis and death.

• 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: 10848290
• MDR Text Key: 218259881
• Report Number: 8030665-2020-01685
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87216
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 83 YR