MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number 050-87216

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

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 02/08/2022

Event Type  Injury  

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy contacted technical support for assistance.During the call the patient reported they had been diagnosed with peritonitis.Upon follow up, the pdrn stated the patient presented to the outpatient home dialysis clinic on (b)(6) 2022 with complaints of abdominal pain and cloudy peritoneal effluent fluid.The cause of the patient¿s peritonitis was attributed to a lack of aseptic technique due to an unspecified touch contamination event involving poor hand hygiene.The patient¿s culture results were positive for staphylococcus epidermidis on (b)(6) 2022.The patient was treated with intravenous (iv) vancomycin and ceftazidime; dose, frequency, duration were not reported.The patient completed the course of antibiotics and has recovered from the events.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review:a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the adverse event of peritonitis, characterized by abdominal pain and cloudy peritoneal effluent fluid, which required antibiotic therapy.Causality was attributed to a touch contamination event; however, specifics were not provided.Per the pdrn, the serious adverse events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s).Staphylococcus epidermidis is part of the normal human biota and is commonly found on the skin, anterior nares, and axillae.Based on the information available, the 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) deficiency or malfunction caused and/or contributed to the serious adverse events.It is well established those individuals undergoing pd therapy are at high risk for infections of the peritoneum.

Manufacturer Narrative

Upon further review of this file it was determined the event was submitted under the incorrect manufacturer and therefore an incorrect mfr number was generated, therefore no further updates will be made on 2937457-2022-00448, and mdr with mfr was submitted with the correct manufacturer.

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy contacted technical support for assistance.During the call the patient reported they had been diagnosed with peritonitis.Upon follow up, the pdrn stated the patient presented to the outpatient home dialysis clinic on (b)(6) 2022 with complaints of abdominal pain and cloudy peritoneal effluent fluid.The cause of the patient¿s peritonitis was attributed to a lack of aseptic technique due to an unspecified touch contamination event involving poor hand hygiene.The patient¿s culture results were positive for staphylococcus epidermidis on (b)(6) 2022.The patient was treated with intravenous (iv) vancomycin and ceftazidime; dose, frequency, duration were not reported.The patient completed the course of antibiotics and has recovered from the events.

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy contacted technical support for assistance.During the call the patient reported they had been diagnosed with peritonitis.Upon follow up, the pdrn stated the patient presented to the outpatient home dialysis clinic on (b)(6) 2022 with complaints of abdominal pain and cloudy peritoneal effluent fluid.The cause of the patient¿s peritonitis was attributed to a lack of aseptic technique due to an unspecified touch contamination event involving poor hand hygiene.The patient¿s culture results were positive for staphylococcus epidermidis on (b)(6) 2022.The patient was treated with intravenous (iv) vancomycin and ceftazidime; dose, frequency, duration were not reported.The patient completed the course of antibiotics and has recovered from the events.

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 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.A review of the user guide was performed.The user guide states as a warning before starting the treatment, ¿you must use aseptic technique as directed by your pd nurse to prevent infection¿.At this time, the reported incident could be attributed to end user error in accordance with the complaint description.As the complaint sample was not available a physical evaluation could not be performed, therefore the alleged event could not be confirmed.

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy contacted technical support for assistance.During the call the patient reported they had been diagnosed with peritonitis.Upon follow up, the pdrn stated the patient presented to the outpatient home dialysis clinic on (b)(6) 2022 with complaints of abdominal pain and cloudy peritoneal effluent fluid.The cause of the patient¿s peritonitis was attributed to a lack of aseptic technique due to an unspecified touch contamination event involving poor hand hygiene.The patient¿s culture results were positive for staphylococcus epidermidis on (b)(6) 2022.The patient was treated with intravenous (iv) vancomycin and ceftazidime; dose, frequency, duration were not reported.The patient completed the course of antibiotics and has recovered from the events.

Manufacturer Narrative

Correction: the statement submitted h10 of follow up 1 was incorrect.This mfr with number 8030665-2022-00363 remains a reportable event.All further updates will be made in 8030665-2022-00363.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13970663
• MDR Text Key: 288383559
• Report Number: 8030665-2022-00363
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• 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: 04/01/2022
• 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.; DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male