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 Abdominal Pain (1685); Peritonitis (2252); Malaise (2359)

Event Date 05/02/2022

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the adverse event of peritonitis, characterized by general illness and abdominal pain.It is well established pd patients are at high risk for infections of the peritoneum.The cause of the patient¿s peritonitis can be attributed to non-adherence to aseptic technique during ccpd therapy as reported by a medical professional.Non-adherence to aseptic technique or ¿touch contamination¿ is the leading cause of transmission of peritonitis causing pathogens.This is further evidenced by the presence of a microorganism that is part of the normal flora of the human hands, skin and nasal passages.Therefore, the liberty cycler set can be excluded as a root cause or contributor to this patient¿s adverse event.Based on the required information, there was no allegation or objective evidence any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

A peritoneal dialysis registered nurse [(pd)rn] reported this pd patient was suspected of contracting peritonitis and experienced drain complications during pd therapy.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient presented to the outpatient clinic on (b)(6) 2022 generally ill with abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the outpatient clinic on (b)(6) 2022 (the patient returned the following day with effluent sample) presented with staphylococcus aureus and a white blood cell (wbc) count of 7988/mm3.The patient was diagnosed with peritonitis due to a break in aseptic technique during ccpd therapy on the liberty select cycler at home.It was explained due to the patient¿s advanced age, his daughter assists with pd treatments, and she does not always take aseptic precautions.The patient was not hospitalized for this event and initially prescribed intraperitoneal (ip) vancomycin at 1500 mg every three days for two weeks and ip gentamycin at 100 mg every day for two weeks.The ip gentamycin was discontinued upon culture results.The patient is recovering from this event while remaining asymptomatic.Additionally, the patient¿s drain complications have resolved with the treatment of the peritonitis infection.It was confirmed the patient¿s peritonitis and the associated drain complications were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home following this event.

Event Description

A peritoneal dialysis registered nurse [(pd)rn] reported this pd patient was suspected of contracting peritonitis and experienced drain complications during pd therapy.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient presented to the outpatient clinic on (b)(6) 2022 generally ill with abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the outpatient clinic on (b)(6) 2022 (the patient returned the following day with effluent sample) presented with staphylococcus aureus and a white blood cell (wbc) count of 7988/mm3.The patient was diagnosed with peritonitis due to a break in aseptic technique during ccpd therapy on the liberty select cycler at home.It was explained due to the patient¿s advanced age, his daughter assists with pd treatments, and she does not always take aseptic precautions.The patient was not hospitalized for this event and initially prescribed intraperitoneal (ip) vancomycin at 1500 mg every three days for two weeks and ip gentamycin at 100 mg every day for two weeks.The ip gentamycin was discontinued upon culture results.The patient is recovering from this event while remaining asymptomatic.Additionally, the patient¿s drain complications have resolved with the treatment of the peritonitis infection.It was confirmed the patient¿s peritonitis and the associated drain complications were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on the same liberty select cycler at home following this event.

Manufacturer Narrative

Additional information: g1, h6 health effect - clinical code 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.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.

• 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; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14396443
• MDR Text Key: 291814190
• Report Number: 0008030665-2022-00551
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/03/2022
• 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; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 98 YR
• Patient Sex: Male
• Patient Weight: 83 KG