MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number	050-95004
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	02/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted customer support and reported they got peritonitis while on the machine.Upon follow up, the peritoneal dialysis registered nurse (pdrn) stated that the patient presented to the outpatient home dialysis unit on (b)(6) 2023 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc = 3305 u/l, polymorphs = 88%) were collected, and the patient was diagnosed with peritonitis.The patient was treated as an outpatient with intraperitoneal (ip) vancomycin (per vancomycin level) and ceftazidime 1500 mg daily for 14-21 days.The patient¿s peritoneal effluent culture result returned negative for growth on (b)(6) 2023, and the patient¿s antibiotics were continued.The patient continues to undergo continuous cyclic pd (ccpd) utilizing the same liberty select cycler and is recovering from the serious adverse events.The pdrn attributed causality to a disconnection event, when the patient¿s pd catheter extension set disconnected from the liberty cycler set due to inadequate tightening.The patient reported the liberty cycler set fell to the floor, and they reconnected without utilizing a new set-up.Per the pdrn, the events were unrelated to any fresenius product(s), drug(s), and/or device(s) deficiency or malfunction.
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 cycler set and the serious adverse event of peritonitis, characterized by abdominal pain and cloudy peritoneal effluent fluid, which warranted antibiotic therapy.The pdrn attributed causality to a disconnection event, when the patient¿s pd catheter extension set disconnected from the liberty cycler set due to improper tightening.The liberty cycler set fell to the floor, and the patient reconnected without utilizing a new set-up.The pdrn stated the serious adverse events were unrelated to any fresenius device(s) and/or product(s).Esrd patients undergoing pd therapy (manual or cycler based) for rrt are at high risk for infections of the peritoneum.Furthermore, in up to 20% of peritonitis cases no offending organism is identified.Based on the information available, the patient¿s liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius product(s) and/or device(s) caused or contributed to the serious adverse events.Furthermore, there was no report a fresenius device(s) and/or product(s) failed to meet user expectations or manufacturer specifications.
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.A review of the user guide was performed.The user guide states as a warning before starting the treatment, ¿you must use aseptic technique as directed by your pd nurse to prevent infection¿.At this time, the reported incident could be attributed to end user error in accordance with the complaint description.As the complaint sample was not available a physical evaluation could not be performed, therefore the alleged event could not be confirmed.
Event or Problem Description
A peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted customer support and reported they got peritonitis while on the machine.Upon follow up, the peritoneal dialysis registered nurse (pdrn) stated that the patient presented to the outpatient home dialysis unit on 20/feb/2023 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc = 3305 u/l, polymorphs = 88%) were collected, and the patient was diagnosed with peritonitis.The patient was treated as an outpatient with intraperitoneal (ip) vancomycin (per vancomycin level) and ceftazidime 1500 mg daily for 14-21 days.The patient¿s peritoneal effluent culture result returned negative for growth on 25/feb/2023, and the patient¿s antibiotics were continued.The patient continues to undergo continuous cyclic pd (ccpd) utilizing the same liberty select cycler and is recovering from the serious adverse events.The pdrn attributed causality to a disconnection event, when the patient¿s pd catheter extension set disconnected from the liberty cycler set due to inadequate tightening.The patient reported the liberty cycler set fell to the floor, and they reconnected without utilizing a new set-up.Per the pdrn, the events were unrelated to any fresenius product(s), drug(s), and/or device(s) deficiency or malfunction.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16491535
• Report Number: 0008030665-2023-00246
• Device Sequence Number: 12459231
• Product Code: KDJ
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 050-95004
• Device Catalogue Number: 050-95004
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 47 KG