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

Catalog Number RTLR180343

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

Patient Problems Pneumonia (2011); Urinary Tract Infection (2120); Peritonitis (2252)

Event Date 07/26/2023

Event Type  Injury  

Manufacturer Narrative

Clinical review: there is a temporal relationship between pd therapy utilizing the liberty select cycler and the patient event of peritonitis with hospitalization.However, there is no documentation in the complaint file to show a causal relationship between the adverse event and use of the liberty select cycler.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for the peritonitis event.Although no information was provided related to culture results or the determined cause of the peritonitis, it was suspected that the patient change dialysis treatment cleaning habits which caused the peritonitis.All pd patients are at risk of peritonitis due to a compromised immune system and the increase of potential for microbial contamination from dialysis techniques.Most cases of peritonitis are caused by touch contamination by the patient with the pd catheter being a source of entry for organisms into the peritoneum.There is no available information related to the patient¿s uti and pneumonia.However, there is no indication that either is related to dialysis or use of any fresenius product(s).The patient reportedly had severe constipation at the time of hospitalization which could be the cause of the uti.Based on the limited information and no allegation of a malfunction, deficiency, or defect the liberty select cycler can be excluded as the cause of the patient¿s reported peritonitis, pneumonia, and uti event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A peritoneal dialysis registered nurse [(pd)rn] reported that this pd patient was hospitalized for peritonitis and pneumonia.Additional information was obtained through follow-up with the pdrn.The patient was admitted to the hospital on (b)(6) 2023.The admitting diagnosis was peritonitis, urinary tract infection (uti), and pneumonia.The patient was severely constipated at the time of hospitalization.There is no information related to pd effluent culture results or antibiotic therapy.Additionally, there is no information related to the uti or pneumonia.The patient was discharged on (b)(6) 2023 and has transitioned to in-center hemodialysis.The patient¿s son reported that the patient was cleaning their pd exit site and catheter a different way.This is believed to be the cause of the peritonitis event; however, it was not confirmed.No additional information was provided.

Event Description

A peritoneal dialysis registered nurse [(pd)rn] reported that this pd patient was hospitalized for peritonitis and pneumonia.Additional information was obtained through follow-up with the pdrn.The patient was admitted to the hospital on (b)(6) 2023.The admitting diagnosis was peritonitis, urinary tract infection (uti), and pneumonia.The patient was severely constipated at the time of hospitalization.There is no information related to pd effluent culture results or antibiotic therapy.Additionally, there is no information related to the uti or pneumonia.The patient was discharged on 04/aug/2023 and has transitioned to in-center hemodialysis.The patient¿s son reported that the patient was cleaning their pd exit site and catheter a different way.This is believed to be the cause of the peritonitis event; however, it was not confirmed.No additional information was 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.

Event Description

A peritoneal dialysis registered nurse [(pd)rn] reported that this pd patient was hospitalized for peritonitis and pneumonia.Additional information was obtained through follow-up with the pdrn.The patient was admitted to the hospital on (b)(6) 2023.The admitting diagnosis was peritonitis, urinary tract infection (uti), and pneumonia.The patient was severely constipated at the time of hospitalization.There is no information related to pd effluent culture results or antibiotic therapy.Additionally, there is no information related to the uti or pneumonia.The patient was discharged on (b)(6) 2023 and has transitioned to in-center hemodialysis.The patient¿s son reported that the patient was cleaning their pd exit site and catheter a different way.This is believed to be the cause of the peritonitis event; however, it was not confirmed.No additional information was provided.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the cycler was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no sign of physical damage.A simulated treatment using (as-received) treatment settings with reduced dwell times was performed and completed without failures.No fluid leaks in the test cassette during the treatment test.The system air leak test and valve actuation test were performed and passed.The internal inspection of the cycler showed found no discrepancies.There were no malfunctions found during testing that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

• 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: 17482634
• MDR Text Key: 320632895
• Report Number: 0002937457-2023-01143
• Device Sequence Number: 1
• Product Code: FKX
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2012
• 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: 79 YR
• Patient Sex: Female