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

Model Number	180237
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical investigation: there is a temporal relationship between pd therapy utilizing the liberty pdx cycler and cycler set and the patient event of peritonitis.However, there is no documentation in the complaint file to show a causal relationship between use of the cycler and cycler set and the peritonitis event.Additionally, there is no allegation of a device malfunction or deficiency or cycler set defect reported for this event.The pdrn suspects the patient had a breach in aseptic technique based on the culture result of pseudomonas luteola.This organism is often found in soil, water and other damp environments and is an opportunistic pathogen for immunocompromised patients especially those with indwelling catheters.All dialysis patients are at increased risk of infection due to weakened immune defenses and the increase of microbial contamination due to dialysis techniques.Based on the available information and no allegation of a malfunction, deficiency, or defect, the liberty pdx cycler and cycler set can be excluded as the cause of the patient¿s peritonitis event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient has been instilling antibiotics via capd daily with no issues.Technical support discussed possible increased fibrin production due to a known infection the patient is being treated for as well as constipation.Upon follow-up with the pd registered nurse (pdrn) revealed the patient was seen in the pd clinic for a report of cloudy pd effluent.The patient did not report any physical symptoms.A pd effluent culture was obtained, and the patient was diagnosed with peritonitis.The patient was initiated on antibiotic therapy.The patient was prescribed intraperitoneal (ip) gentamycin daily to be instilled with a manual exchange for a 6-hour dwell (dose and duration not provided).The pd effluent culture resulted positive for pseudomonas luteola, a gram-negative aerobic bacillus.The patient did not require hospitalization for the event.The cause of the peritonitis was not determined; however, the pdrn reported there was most likely a breach in aseptic technique based on the organism.There was no report of a cassette leak or other issue related to the liberty pdx cycler.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient has been instilling antibiotics via capd daily with no issues.Technical support discussed possible increased fibrin production due to a known infection the patient is being treated for as well as constipation.Upon follow-up with the pd registered nurse (pdrn) revealed the patient was seen in the pd clinic for a report of cloudy pd effluent.The patient did not report any physical symptoms.A pd effluent culture was obtained, and the patient was diagnosed with peritonitis.The patient was initiated on antibiotic therapy.The patient was prescribed intraperitoneal (ip) gentamycin daily to be instilled with a manual exchange for a 6-hour dwell (dose and duration not provided).The pd effluent culture resulted positive for pseudomonas luteola, a gram-negative aerobic bacillus.The patient did not require hospitalization for the event.The cause of the peritonitis was not determined; however, the pdrn reported there was most likely a breach in aseptic technique based on the organism.There was no report of a cassette leak or other issue related to the liberty pdx cycler.
Additional 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 PDX CYCLER ASSY (NON-VALUATED)
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 11564109
• Report Number: 2937457-2021-00497
• Device Sequence Number: 19572139
• Product Code: FKX
• UDI-Device Identifier: 00840861100989
• UDI-Public: 00840861100989
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K141145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 180237
• Device Catalogue Number: RTLR180237
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 73