MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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

Patient Problems Inflammation (1932); Peritonitis (2252)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

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 select cycler with the liberty cycler set and the adverse events of peritonitis.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 intra-abdominal sources as reported by a medical professional.Though a less common source of peritonitis infections, it is well known transmission of peritonitis causing pathogens can be from intra-abdominal sources, particularly in the environment of an active gi infection.Therefore, the liberty select cycler and 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.Should additional information become available related to any fresenius device(s) and/or product(s), please re-submit for a clinical review and the need for a clinical investigation will be reassessed accordingly.

Event Description

It was reported a peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler experienced bowel inflammation and presented to the emergency department (ed).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 (b)(6) and was hospitalized on (b)(6) 2022 for an undetermined gastrointestinal (gi) illness.The patient did not experience symptoms on or around the time of a pd treatment.The patient recently had a covid-19 infection and a clostridium difficile lower gi infection (dates of diagnoses unknown), both diagnoses determined to be unrelated to pd therapy or the use of any fresenius product(s) or device(s).The patient¿s pd catheter (not a fresenius product) was removed due to severity of the bowel inflammation and the patient underwent hemodialysis (hd) for renal replacement therapy on a hospital provided hd machine (unknown brand and model) for the duration of the admission.The patient was diagnosed with peritonitis due to intra-abdominal sources while hospitalized; however, peritoneal effluent fluid cultures and white blood cell (wbc) count results were not provided to the outpatient clinic.The patient was given intravenous antibiotics for multiple infections while hospitalized but the type, route, dose and frequency were not reported to the outpatient clinic.The patient is recovering from this event while awaiting discharge.It was confirmed the patient¿s unspecified gi illness, covid-19 infection, clostridium difficile gi infection and associated bowel inflammation were unrelated to pd therapy or the use of any fresenius product(s) or device(s).Additionally, it was affirmed the patient¿s peritonitis, and hospitalization were not due to a deficiency or malfunction of nay fresenius product(s) or device(s).The patient will continue hd on an in-center basis upon discharge with plans to return to pd therapy once cleared by his nephrologist.

Manufacturer Narrative

Correction: b5.

Event Description

It was reported a peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler experienced bowel inflammation and presented to the emergency department (ed).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 ed and was hospitalized on (b)(6) 2022 for an undetermined gastrointestinal (gi) illness.The patient did not experience symptoms on or around the time of a pd treatment.The patient recently had a covid-19 infection and a clostridium difficile lower gi infection (dates of diagnoses unknown), both diagnoses determined to be unrelated to pd therapy or the use of any fresenius product(s) or device(s).The patient¿s pd catheter (not a fresenius product) was removed due to severity of the bowel inflammation and the patient underwent hemodialysis (hd) for renal replacement therapy on a hospital provided hd machine (unknown brand and model) for the duration of the admission.The patient was diagnosed with peritonitis due to intra-abdominal sources while hospitalized; however, peritoneal effluent fluid cultures and white blood cell (wbc) count results were not provided to the outpatient clinic.The patient was given intravenous antibiotics for multiple infections while hospitalized but the type, route, dose and frequency were not reported to the outpatient clinic.The patient is recovering from this event while awaiting discharge.It was confirmed the patient¿s unspecified gi illness, covid-19 infection, clostridium difficile gi infection and associated bowel inflammation were unrelated to pd therapy or the use of any fresenius product(s) or device(s).Additionally, it was affirmed the patient¿s peritonitis, and hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient will continue hd on an in-center basis upon discharge with plans to return to pd therapy once cleared by his nephrologist.

Event Description

It was reported a peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler experienced bowel inflammation and presented to the emergency department (ed).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 ed and was hospitalized on (b)(6) 2022 for an undetermined gastrointestinal (gi) illness.The patient did not experience symptoms on or around the time of a pd treatment.The patient recently had a covid-19 infection and a clostridium difficile lower gi infection (dates of diagnoses unknown), both diagnoses determined to be unrelated to pd therapy or the use of any fresenius product(s) or device(s).The patient¿s pd catheter (not a fresenius product) was removed due to severity of the bowel inflammation and the patient underwent hemodialysis (hd) for renal replacement therapy on a hospital provided hd machine (unknown brand and model) for the duration of the admission.The patient was diagnosed with peritonitis due to intra-abdominal sources while hospitalized; however, peritoneal effluent fluid cultures and white blood cell (wbc) count results were not provided to the outpatient clinic.The patient was given intravenous antibiotics for multiple infections while hospitalized but the type, route, dose and frequency were not reported to the outpatient clinic.The patient is recovering from this event while awaiting discharge.It was confirmed the patient¿s unspecified gi illness, covid-19 infection, clostridium difficile gi infection and associated bowel inflammation were unrelated to pd therapy or the use of any fresenius product(s) or device(s).Additionally, it was affirmed the patient¿s peritonitis, and hospitalization were not due to a deficiency or malfunction of nay fresenius product(s) or device(s).The patient will continue hd on an in-center basis upon discharge with plans to return to pd therapy once cleared by his nephrologist.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.No shipping search could be performed for the lots delivered to the patient since there is no patient number reported or additional information for the search.Consequently no product will be returned from the distribution center to be analyzed since the lot number is unknown and no information from the patient is available for the identified of the possible involved lots.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: FMC CASSETTE
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13661320
• MDR Text Key: 286749177
• Report Number: 8030665-2022-00209
• Device Sequence Number: 1
• Product Code: FKX
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/23/2022
• 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; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 103 KG