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 Myocardial Infarction (1969); Peritonitis (2252)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: it is unknown if a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the serious adverse events of an stemi (requiring hospitalization) and peritonitis, which reportedly required the patient to transition to another form of rrt.The etiology and timeline of events is unknown; therefore, causality cannot be established.However, the pdrn¿s response did not indicate a fresenius device(s) and/or product(s) malfunctioned or was deficient in any way.Myocardial infarctions are a widespread complication for patients undergoing maintenance dialysis due to their underlying and often complex cardiovascular and endocrine status.Additionally, those individuals undergoing pd therapy (manual or cycler based) are at high risk for infections of the peritoneum.Based on the information available, the liberty select cycler and liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused and/or contributed to the serious adverse events.Furthermore, there was no report a fresenius product(s) and/or device(s) failed to meet the users¿ expectations or manufacturers¿ specifications.

Event Description

On 08/08/2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized.During intake, the pd registered nurse (pdrn) reported the patient contracted peritonitis while hospitalized and is no longer able to perform pd therapy.A written response from the patient¿s pdrn revealed the patient was hospitalized (admission date not provided, >30-day hospitalization) due to a st elevation myocardial infarction (stemi).It was reported the patient developed peritonitis while admitted and required transition to alternate form of rrt (modality type not provided).As of 08/09/2023, the patient remained hospitalized and is recovering from the serious adverse events.Additional information (e.G., hospital records, medication records, treatment records) was requested, however the patient¿s medical record was closed.The patient was discharged from the outpatient home program after being hospitalized for >30 days.Additional information was requested however the request could not be fulfilled as the patient¿s electronic medical record was closed.

Event Description

On 08/08/2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized.During intake, the pd registered nurse (pdrn) reported the patient contracted peritonitis while hospitalized and is no longer able to perform pd therapy.A written response from the patient¿s pdrn revealed the patient was hospitalized (admission date not provided, >30-day hospitalization) due to a st elevation myocardial infarction (stemi).It was reported the patient developed peritonitis while admitted and required transition to alternate form of rrt (modality type not provided).As of (b)(6) 2023, the patient remained hospitalized and is recovering from the serious adverse events.Additional information (e.G., hospital records, medication records, treatment records) was requested, however the patient¿s medical record was closed.The patient was discharged from the outpatient home program after being hospitalized for >30 days.Additional information was requested however the request could not be fulfilled as the patient¿s electronic medical record was closed.

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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17625133
• MDR Text Key: 321971956
• Report Number: 0008030665-2023-00781
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/28/2023
• 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; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 62 KG