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

Model Number 180343

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

Patient Problems Peritonitis (2252); Malaise (2359)

Event Date 10/16/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler with the liberty cycler set and the adverse events of peritonitis, characterized by a general ill feeling by the patient.It is well established pd patients are at high risk for infections of the peritoneum.The source of the patient¿s peritonitis cannot be determined as there was no confirmed source; however, it was confirmed there was no deficiency or malfunction of the patient¿s dialysate solution as reported by a medical professional.Though the source of this infection was unknown, fungal infections involving candida spp.Originate from human skin, gastrointestinal tracts and genitourinary tracts with most transmissions resulting from touch contamination.In the absence of a confirmed source of this event, the liberty select cycler and liberty cycler set cannot be excluded as a root cause or contributor to this event.Based on the available information, there was no specific allegation or objective evidence any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

A peritoneal dialysis nurse (pdrn) for a peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted customer support to report that a patient had peritonitis.Upon follow up, the pdrn stated the patient was hospitalized for peritonitis due to not feeling well (signs and symptoms unknown).The pdrn stated the patient was admitted to the hospital on 10/16/2021 and still remains in the hospital recovering.The cause of the patient¿s peritonitis was unknown as the patient practices aseptic technique and has not had any reported fluid leaks.The pdrn stated that the patient did have a culture taken which was positive for peritonitis, the culture was taken on (b)(6) 2021 and the culture came back positive for candida polyphemus.The patient was prescribed antibiotics, vancomycin (iv, dose of 2 grams), fortex (2 grams) for a duration of 4 days.The pdrn stated that the patient has been switched to hd therapy since (b)(6) 2021 and has been continuing hd therapy without reoccurrence of the event.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

Manufacturer Narrative

Additional information: g1 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 nurse (pdrn) for a peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted customer support to report that a patient had peritonitis.Upon follow up, the pdrn stated the patient was hospitalized for peritonitis due to not feeling well (signs and symptoms unknown).The pdrn stated the patient was admitted to the hospital on (b)(6) 2021 and still remains in the hospital recovering.The cause of the patient¿s peritonitis was unknown as the patient practices aseptic technique and has not had any reported fluid leaks.The pdrn stated that the patient did have a culture taken which was positive for peritonitis, the culture was taken on (b)(6) 2021 and the culture came back positive for candida polyphemus.The patient was prescribed antibiotics, vancomycin (iv, dose of 2 grams), fortex (2 grams) for a duration of 4 days.The pdrn stated that the patient has been switched to hd therapy since (b)(6) 2021 and has been continuing hd therapy without reoccurrence of the event.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12704303
• MDR Text Key: 278573105
• Report Number: 2937457-2021-02154
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/26/2021

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: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2017
• 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; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 108 KG