MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 180343

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 select cycler 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 actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.Although there was evidence of dried fluid present within the cassette compartment, there were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.There were visual indications of particulates within the cassette area.An accelerated stress test (ast) was performed on the cycler and passed.There were no fluid leaks in the test cassette during the accelerated stress test.The cycler underwent and passed a system air leak test, valve actuation test, and patient sensor calibration check.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.An internal visual inspection identified evidence of dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the dried fluid could not be determined.There was a visual evidence of a clog in hp2 and hp3 filters which is a failure related to the reported air detected in cassette alarm.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

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 28/feb/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.

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 (b)(4).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: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 13792085
• MDR Text Key: 287410212
• Report Number: 2937457-2022-00403
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181108
• 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: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 57 KG