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

Model Number 180111

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

Patient Problems Nausea (1970); Urinary Tract Infection (2120); Vomiting (2144); Weakness (2145); Electrolyte Imbalance (2196); Peritonitis (2252); Urinary Frequency (2275); Respiratory Failure (2484); Confusion/ Disorientation (2553); Hypervolemia (2664)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed.There is a temporal relationship between pd therapy utilizing the liberty select cycler and the patient hospitalization for confusion and weakness with subsequent diagnosis of hyperkalemia, uti, peritonitis, volume overload and acute hypoxemic respiratory failure.However, there is no documentation in the complaint file that shows a causal relationship between the hospitalization diagnoses and utilization of the liberty select cycler with cycler set.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.It was documented that the patient¿s pd catheter was most likely blocked which caused the patient incomplete treatments resulting in fluid overload and electrolyte imbalance.The cause of the peritonitis was not documented; however, there is no report of a cycler set leak or defect reported for the event.The patient¿s pdrn stated the hospitalization was unrelated to the cycler use.All pd patients are at increased risk of infection due to a compromised immune system and the dialysis techniques which increase risk of microbial contamination.The majority of pd related peritonitis is caused by a breach in aseptic technique by the patient as they are handling the pd catheter connections or the pd catheter itself.Based on the available information and no allegation of a malfunction, deficiency or defect, the liberty select cycler and cycler set can be excluded as the cause of the patient¿s peritonitis and fluid volume overload with resulting acute hypoxemic respiratory failure.Urinary tract infections are most often caused by bacteria normally found in the digestive system and is unrelated to use of the liberty select cycler.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) reported that they were hospitalized due to drain complication.Additional information was obtained through the patient¿s peritoneal dialysis registered nurse (pdrn) and the medical records review from the hospitalization.On (b)(6) 2020 the patient experienced nausea and vomiting.On (b)(6) 2020 the patient presented to the emergency room (er) with confusion and weakness.Upon arrival to the er the patient¿s vitals were as follows: blood pressure (bp) 171/112, pulse 96, respirations 20, temperature 99.7°, and spo2 97%.The patient¿s weight was (b)(6) kg with no signs of edema.Initially the patient¿s spouse reported the patient had incomplete pd treatments for two days due to machine issues, but later reported that a pd catheter (not a fresenius product) obstruction was suspected as causing draining issues.The pdrn¿s documentation stated the hospitalization admission was not cycler related.In the er a urine culture was obtained which showed pyuria with a white blood cell (wbc) count of 20.A uti was diagnosed although the urine culture was negative for growth.The patient also had hyperkalemia with a lab value of 6.3 and was administered calcium (unknown dose).The patient was admitted to the hospital and put on broad spectrum antibiotic therapy.The patient became hypoxemic once on the floor and required bipap treatment with supplemental oxygen (o2).The patient¿s physical findings at the time were consistent with fluid volume overload.After consultation with the nephrologist, the patient was initiated on pd therapy with aggressive ultrafiltration (uf).The patient¿s pd effluent was then noted to be cloudy and a culture was obtained on (b)(6) 2020.The wbc count for the pd effluent was 4198/ccmm and peritonitis was diagnosed.The culture resulted negative for growth per the documentation.The patient was initiated on intraperitoneal (ip) vancomycin and ceftazidime (dose, frequency, and duration unknown).The patient was eventually moved to the critical care unit (ccu) for monitoring and treatment of hypoxemic respiratory failure.The patient tested negative for covid-19 and sars.A chest x-ray on (b)(6) 2020 showed possible development of early infiltrates or edema, but improvement with near resolution was determined with x-ray on (b)(6) 2020.The patient¿s confusion was attributed to the uti and peritonitis.The patient improved and was removed from bipap and o2.The patient was discharged to home on (b)(6) 2020 and was to continue the ip vancomycin and ceftazidime for three weeks.The cause of the peritonitis was not documented.

Manufacturer Narrative

Correction :h6 patient harm code 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: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10091357
• MDR Text Key: 193288913
• Report Number: 2937457-2020-00939
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180111
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 89