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

Catalog Number	RTLR180237
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical investigation: there is a temporal relationship between pd therapy utilizing the liberty pdx cycler with the liberty pdx integrated set and the patient event of peritonitis.However, there is no documentation in the complaint file to show a causal relationship.Additionally, there is no allegation of a device malfunction or deficiency or reported leak from the integrated set reported for this event.Traditionally, gram positive bacteria are found in the normal flora of human skin, or in soil and water.It is unknown if the patient practiced proper aseptic technique.Based on the available information, the liberty pdx cycler and pdx integrated set can be excluded as the cause of the peritonitis.Should additional information become available related to a fresenius device(s) and/or product(s), please re-submit for a clinical review and the need for a clinical investigation will be reassessed accordingly.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 or Problem Description
A peritoneal dialysis (pd) patient's contact reported that the patient was diagnoses with peritonitis.Upon follow up with the patient's pd registered nurse (pdrn) it was reported that the patient presented to the clinic on (b)(6) 2019 with cloudy pd effluent.The patient was initiated on antibiotic therapy with intraperitoneal (ip) vancomycin and ceftazidime (dose, frequency and duration unknown).The pd effluent culture was obtained and was positive for gram positive bacteria (genus and species requested but not provided) with a white cell count of 606 (unknown units).After the culture results were obtained, the ceftazidime prescription was removed and the patient only remained on ip vancomycin with the last dose expected (b)(6) 2019.The cause of the peritonitis is unknown, but the pdrn stated there were no issues with the liberty pdx cycler or liberty pdx integrated set.The patient did not require hospitalization for the peritonitis event.The patient continued with pd treatment on the cycler without any issues during their recovery.No samples were returned to the manufacturer for physical evaluation.

• Brand Name: LIBERTY PDX CYCLER ASSY (NON-VALUATED)
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8831761
• Report Number: 2937457-2019-02312
• Device Sequence Number: 262327
• Product Code: FKX
• UDI-Device Identifier: 00840861100989
• UDI-Public: 00840861100989
• Combination Product (Y/N): N
• PMA/510(K) Number: K141145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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 Catalogue Number: RTLR180237
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR