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 Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	11/15/2019
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 cycler, liberty pdx integrated set and the adverse events of peritonitis, characterized by abdominal pain, which warranted antibiotic therapy.The pdrn stated the cause of the peritonitis was touch contamination due to the patient handling the pd catheter (not a fresenius product) without wearing gloves.Per the pdrn, the events are unrelated to the utilization of the liberty pdx cycler, liberty pdx integrated set or any fresenius product(s) or device(s).Individuals undergoing pd therapy are at high risk for infections of the peritoneum.Additionally, in up to 20% of peritonitis cases, no offending organism is identified.Based on the information available, the liberty pdx cycler and liberty pdx integrated set can be disassociated from the events.There is no allegation or objective evidence indicating a fresenius product deficiency or device malfunction caused or contributed to the serious adverse events.Moreover, the patient continues to utilize the same liberty pdx cycler without any reported issue(s).
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient had peritonitis and had ordered manual drain bags and manual solutions.During follow-up, the patient¿s peritoneal dialysis registered nurse (pdrn) reported the patient presented to the outpatient home dialysis clinic on (b)(6) 2019 (discharge date not provided) with abdominal pain.A peritoneal effluent fluid culture was obtained and was negative for growth; however, a cell count revealed an elevated white blood cell (wbc) count of 1203 u/l.The patient was treated as an outpatient with intraperitoneal (ip) vancomycin 1-gram daily for 21 days and has recovered from the events.Per the pdrn, the events were unrelated to the utilization of the liberty pdx cycler, liberty pdx integrated set or any fresenius product(s) or device(s).The cause of the peritonitis was attributed to touch contamination, when the patient touched the pd catheter (not a fresenius product) without donning gloves.The patient continues to undergo ccpd therapy utilizing the same liberty pdx cycler as before the events without issue.Based on the information available, the liberty pdx cycler and liberty pdx integrated set can be disassociated from the events.There is no allegation or objective evidence indicating a fresenius product deficiency or device malfunction caused or contributed to the serious adverse events.
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-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: 9591417
• Report Number: 8030665-2020-00063
• Device Sequence Number: 3244339
• Product Code: FKX
• UDI-Device Identifier: 00840861101993
• UDI-Public: 00840861101993
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 01/08/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 01/29/2020
• 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 CYCLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 89