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 Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	10/15/2019
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: there is a temporal relationship between pd therapy on the liberty pdx cycler with pdx integrated set and the patient event of peritonitis.However, there is no documentation in the complaint file to show a causal relationship between the peritonitis and use of the cycler with integrated set.Per the pdrn, the cause of the peritonitis event was touch contamination by the patient as evidenced by the culture results of staphylococcus epidermidis.These organisms are the predominant normal flora on human skin and are the most frequently identified cause of pd associated peritonitis.Based on the available information, the liberty pdx cycler with pdx integrated set can be excluded as the cause of the peritonitis.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient has peritonitis.Upon follow up with the patient¿s peritoneal dialysis registered nurse (pdrn), the patient had suspected peritonitis on the date of the call to customer support due to cloudy effluent and abdominal pain.On 16/oct/2019 the patient was seen in the pd clinic and diagnosed with peritonitis.A pd effluent culture was obtained, and the patient received a loading dose of intraperitoneal (ip) antibiotics.The patient was administered ip vancomycin 1750ml and ip ceftazidime 2g.The pd effluent culture resulted positive for staphylococcus epidermidis with a white cell count of 377 (unknown units) with 58% polymorphonuclear cells.The ceftazidime was discontinued, and the patient remained on the ip vancomycin (dose, frequency and duration unknown).The patient did not require hospitalization for the event.The cause of the peritonitis has been attributed to touch contamination by the patient.There were no issues with the liberty pdx cycler or pdx integrated set.The patient continues pd therapy with the cycler during recovery.
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: 9234408
• Report Number: 8030665-2019-01643
• Device Sequence Number: 2483606
• 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,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 10/15/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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 CYCLER; DELFLEX PD FLUID; LIBERTY CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR