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

Model 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	09/01/2020
Type of Reportable Event	Serious Injury
Additional 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 pdx integrated set and the adverse event of peritonitis.It is well established for those patients undergoing pd therapy are at high risk for infections of the peritoneum.The cause of the patient¿s peritonitis can be attributed to touch contamination to the liberty pdx integrated set during ccpd therapy at home as reported by the pdrn.This is further evidenced by a microorganism that is the predominant normal flora on human skin and a well-known contributor to peritonitis through touch contamination.Based on the required information, there is no specific allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s adverse event.
Event or Problem Description
A peritoneal dialysis (pd) patient reported to fresenius that they experienced a catheter infection.There was no allegation that the event was due to the deficiency or malfunction of any fresenius product or device.Clarification of the event details were provided via follow-up with the patient's peritoneal dialysis registered nurse (pdrn).The pdrn stated this patient presented to the outpatient clinic with cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the outpatient clinic presented with staphylococcus capitis and a white blood cell count (wbc) of 4/mm3.The patient was diagnosed with peritonitis due to touch contamination during continuous cyclic pd (ccpd) therapy on the liberty pdx cycler at home.The patient was not hospitalized for the event and prescribed intraperitoneal vancomycin at 2000 mg every five days for three weeks.It was confirmed the patient¿s diagnosis of peritonitis was not due to a fresenius device deficiency or malfunction.The patient has recovered from the event and was continuing ccpd therapy on the same liberty pdx cycler at home.
Additional Manufacturer Narrative
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-conformance's 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.The user guide p/n 480145 was reviewed and indicates "you must use aseptic technique as directed by your pd nurse to prevent infection¿.As per the follow up information received, the incident was attributed to end user error.Since the complaint sample was not available for evaluation, the alleged event 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: 10696459
• Report Number: 8030665-2020-01525
• Device Sequence Number: 16908839
• Product Code: FKX
• UDI-Device Identifier: 00840861101993
• UDI-Public: 00840861101993
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 050-87222
• Device Catalogue Number: 050-87222
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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; DELFLEX PD FLUID; LIBERTY PDX CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 73