MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY PDX, INTEGRATED SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	050-87222
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
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), thee need for a clinical investigation will be reassessed accordingly.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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 (b)(6) for gram (b)(6) 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.
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), thee need for a clinical investigation will be reassessed accordingly.Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: LIBERTY PDX, INTEGRATED SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 8831758
• Report Number: 8030665-2019-01150
• Device Sequence Number: 16853648
• Product Code: FKX
• UDI-Device Identifier: 00840861101993
• UDI-Public: 00840861101993
• 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,Followup
• Report Date (Section B): 08/24/2019

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: 050-87222
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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; LIBERTY PDX CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR