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 Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Dehydration (1807); Hemorrhage/Bleeding (1888); Sepsis (2067); Peritonitis (2252); Constipation (3274)

Event Date 02/24/2022

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a possible temporal and causal relationship between pd therapy utilizing the liberty cycler set and the patient event of peritonitis with subsequent sepsis and admittance to the icu due to the reported fluid leak on (b)(6) 2022.However, the patient reportedly had a recent endoscopy for a bowel impaction and suspected gi bleed.Endoscopic procedures can increase the risk of peritonitis in pd patients by inflation and irritation of the bowel wall, leading to the translocation of microbes across the gut wall to other sites such as the peritoneum and the blood stream.The pd effluent result of enterococcus faecalis supports the procedure as the likely cause.Enterococcus faecalis is a normal inhabitant of the gi tract and suggests an intra-abdominal source of infection.Additionally, it is unlikely that the patient experienced a cassette leak on (b)(6) 2022 and developed peritonitis and sepsis within the same day leading to an icu admission.Furthermore, the international society of peritoneal dialysis (ispd) states that peritoneal dialysis peritonitis commonly follows invasive interventional procedures in pd patients.Based on the available information including the culture results and timing of the patient¿s admission to the icu, it is unlikely the fluid leak is the cause of the patient¿s peritonitis event with subsequent sepsis and transition to hospice.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

On (b)(6) 2022 the contact for this peritoneal dialysis (pd) patient contacted fresenius technical support for fill complications and an air detected in cassette warning encountered during treatment on the liberty select cycler.A fluid leak was discovered in the pump module and on the external of the cassette at the end of treatment despite the liberty select cycler alerting the patient with alarms during treatment.During follow-up with the patient contact on (b)(6) 2022, it was reported that this patient was admitted to the intensive care unit (icu) on the same day as the leak (b)(6) 2022).The patient¿s pd effluent was discolored.The patient had a catheter placed in their neck for hemodialysis (hd) treatment.The contact reported that the patient underwent an endoscopy approximately two weeks prior (date unknown) for a bowel impaction which could have caused bacteria to enter the abdomen.Additional follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn) documented that the patient had been experiencing abdominal and pelvic pain, dehydration, constipation, and lack of appetite.Additionally, the patient¿s pd effluent was extremely cloudy with sediment.The patient was admitted to the icu on (b)(6) 2022 with a diagnosis of sepsis related to peritonitis.In addition, the patient was diagnosed with a gastrointestinal (gi) hemorrhage.Per the pdrn, the patient did undergo an endoscopy due to bowel impaction and a suspected gi bleed.The pd effluent culture resulted positive for enterococcus faecium, and the patient¿s white blood cell (wbc) count was 3203/mm3.The antibiotic regimen is unknown as it was administered at the hospital.The patient had the pd catheter pulled and a catheter placed for hd therapy.As of (b)(6) 2022 the patient was transitioned to hospice.The patient remains hospitalized.According to the pdrn, the cause of the peritonitis episode is both the recent fecal disimpaction and the cassette leak.No further details were provided.

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.

Event Description

On (b)(6) 2022 the contact for this peritoneal dialysis (pd) patient contacted fresenius technical support for fill complications and an air detected in cassette warning encountered during treatment on the liberty select cycler.A fluid leak was discovered in the pump module and on the external of the cassette at the end of treatment despite the liberty select cycler alerting the patient with alarms during treatment.During follow-up with the patient contact on (b)(6) 2022, it was reported that this patient was admitted to the intensive care unit (icu) on the same day as the leak ((b)(6) 2022).The patient¿s pd effluent was discolored.The patient had a catheter placed in their neck for hemodialysis (hd) treatment.The contact reported that the patient underwent an endoscopy approximately two weeks prior (date unknown) for a bowel impaction which could have caused bacteria to enter the abdomen.Additional follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn) documented that the patient had been experiencing abdominal and pelvic pain, dehydration, constipation, and lack of appetite.Additionally, the patient¿s pd effluent was extremely cloudy with sediment.The patient was admitted to the icu on (b)(6) 2022 with a diagnosis of sepsis related to peritonitis.In addition, the patient was diagnosed with a gastrointestinal (gi) hemorrhage.Per the pdrn, the patient did undergo an endoscopy due to bowel impaction and a suspected gi bleed.The pd effluent culture resulted positive for enterococcus faecium, and the patient¿s white blood cell (wbc) count was 3203/mm3.The antibiotic regimen is unknown as it was administered at the hospital.The patient had the pd catheter pulled and a catheter placed for hd therapy.As of (b)(6) 2022 the patient was transitioned to hospice.The patient remains hospitalized.According to the pdrn, the cause of the peritonitis episode is both the recent fecal disimpaction and the cassette leak.No further details were provided.

Manufacturer Narrative

Correction: b5 (addition of fluid leak mfrs), h6 (health effect - clinical and medical device problem codes) additional information: g1.

Event Description

On (b)(6) 2022 the contact for this peritoneal dialysis (pd) patient contacted fresenius technical support for fill complications and an air detected in cassette warning encountered during treatment on the liberty select cycler.A fluid leak was discovered in the pump module and on the external of the cassette at the end of treatment despite the liberty select cycler alerting the patient with alarms during treatment (see mfrs 8030665-2022-00208 and 2937457-2022-00340).During follow-up with the patient contact on (b)(6) 2022, it was reported that this patient was admitted to the intensive care unit (icu) on the same day as the leak ((b)(6) 2022).The patient¿s pd effluent was discolored.The patient had a catheter placed in their neck for hemodialysis (hd) treatment.The contact reported that the patient underwent an endoscopy approximately two weeks prior (date unknown) for a bowel impaction which could have caused bacteria to enter the abdomen.Additional follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn) documented that the patient had been experiencing abdominal and pelvic pain, dehydration, constipation, and lack of appetite.Additionally, the patient¿s pd effluent was extremely cloudy with sediment.The patient was admitted to the icu on (b)(6) 2022 with a diagnosis of sepsis related to peritonitis.In addition, the patient was diagnosed with a gastrointestinal (gi) hemorrhage.Per the pdrn, the patient did undergo an endoscopy due to bowel impaction and a suspected gi bleed.The pd effluent culture resulted positive for enterococcus faecium, and the patient¿s white blood cell (wbc) count was 3203/mm3.The antibiotic regimen is unknown as it was administered at the hospital.The patient had the pd catheter pulled and a catheter placed for hd therapy.As of (b)(6) 2022 the patient was transitioned to hospice.The patient remains hospitalized.According to the pdrn, the cause of the peritonitis episode is both the recent fecal disimpaction and the cassette leak.No further details were provided.

• 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: 13792079
• MDR Text Key: 287342317
• Report Number: 8030665-2022-00244
• 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: 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
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• 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
• Device Lot Number: 21LR08033
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2021
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 57 KG