MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87212

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

Patient Problems Abdominal Pain (1685); Low Blood Pressure/ Hypotension (1914); Peritonitis (2252)

Event Date 03/05/2024

Event Type  Injury  

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 the pd therapy with the liberty cycler set and the patient¿s peritonitis event with subsequent hospitalization for hypotension with failure to thrive and death.However, currently there is no allegation nor any objective evidence that a liberty cycler set malfunction or product deficiency was associated with these events.The event of hypotension was associated with medication for pre-existing atrial fibrillation and was not caused by fresenius products.Moreover, peritonitis is a well-documented complication in patients undergoing pd therapy.The patient¿s pd culture grew the bacteria staphylococcus epidermis which is bacteria normally found on human skin.Therefore, based on the reported information, the peritonitis event can be reasonably attributed to a breach in aseptic technique (not wearing a mask) during the pd exchange, as reported by the pd nurse.While the exact cause of death was unknown, there is no temporal association to pd treatment with fresenius products.Additionally, the patient¿s pd nurse reported this elderly patient¿s overall health had been declining over the course of a year and the patient had failure to thrive which are likely to be associated with the reported death.

Event Description

On 26/mar/2024, it was reported by a registered nurse (rn) that this patient on peritoneal dialysis (pd) was hospitalized with peritonitis.In additional follow-up, the patient¿s pd nurse stated the patient was experiencing symptoms of abdominal pain.As a result, on (b)(6) 2024, the patient was initially seen in the outpatient pd clinic and had a pd culture obtained.Per the nurse, the pd culture was positive for the bacteria staphylococcus epidermis.The patient was initiated on intra-peritoneal (ip) vancomycin and ceftazidime (per clinic protocol).Subsequently, on (b)(6) 2024, the patient had low blood pressure (reading not provided) while being seen at the outpatient pd clinic for a second dose of ip antibiotics.Per the nurse, the patient was hospitalized (the same day) for the issue of low pressure.While hospitalized, the patient continued antibiotic therapy (details unknown).The nurse stated the patient¿s peritonitis infection was cleared in the hospital.However, the nurse stated the patient¿s overall health had been declining over the past year and that the patient had failure to thrive and was not eating or drinking in the hospital.Subsequently, on an unknown date while hospitalized, the patient expired.The patient¿s pd nurse stated the patient¿s low pressure was not related to pd therapy.The nurse indicated the event was caused by the medication amiodarone that the patient was started on for atrial fibrillation.Additionally, the pd nurse confirmed the patient did not have any fluid leaks or issues with fresenius products in relation to the peritonitis and fluid overload event.The nurse indicated the peritonitis was due to a breach in aseptic technique during the pd exchange whereby the patient was not wearing a mask.Furthermore, the nurse indicated the exact cause of death was unknown.However, it was reported that the death did not occur during a pd treatment and was not related to fresenius products.

Event Description

On (b)(6) 2024, it was reported by a registered nurse (rn) that this patient on peritoneal dialysis (pd) was hospitalized with peritonitis.In additional follow-up, the patient¿s pd nurse stated the patient was experiencing symptoms of abdominal pain.As a result, on (b)(6) 2024, the patient was initially seen in the outpatient pd clinic and had a pd culture obtained.Per the nurse, the pd culture was positive for the bacteria staphylococcus epidermis.The patient was initiated on intra-peritoneal (ip) vancomycin and ceftazidime (per clinic protocol).Subsequently, on (b)(6) 2024, the patient had low blood pressure (reading not provided) while being seen at the outpatient pd clinic for a second dose of ip antibiotics.Per the nurse, the patient was hospitalized (the same day) for the issue of low pressure.While hospitalized, the patient continued antibiotic therapy (details unknown).The nurse stated the patient¿s peritonitis infection was cleared in the hospital.However, the nurse stated the patient¿s overall health had been declining over the past year and that the patient had failure to thrive and was not eating or drinking in the hospital.Subsequently, on an unknown date while hospitalized, the patient expired.The patient¿s pd nurse stated the patient¿s low pressure was not related to pd therapy.The nurse indicated the event was caused by the medication amiodarone that the patient was started on for atrial fibrillation.Additionally, the pd nurse confirmed the patient did not have any fluid leaks or issues with fresenius products in relation to the peritonitis and fluid overload event.The nurse indicated the peritonitis was due to a breach in aseptic technique during the pd exchange whereby the patient was not wearing a mask.Furthermore, the nurse indicated the exact cause of death was unknown.However, it was reported that the death did not occur during a pd treatment and was not related to fresenius products.

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.There is no allegation of cassette malfunction based in the complaint description and information provided the reported peritonitis was attributed to a breach in aseptic technique.There is no allegation of cassette malfunction.As there is no allegation related to product manufacture, the complaint is deemed as unconfirmed.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 19061300
• MDR Text Key: 339674563
• Report Number: 0008030665-2024-00334
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/24/2024
• 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): Hospitalization; Death; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female