MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 050-87216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Chills (2191); Peritonitis (2252); Malaise (2359)

Event Date 03/09/2023

Event Type  Injury  

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 select cycler with the liberty cycler set and the adverse event of peritonitis, characterized by abdominal pain, malaise and chills.It is well established that pd patients are at high risk for infections of the peritoneum.The root cause of this patient¿s peritonitis cannot be determined at this time; however, there was no indication this patient¿s infection was due to a deficiency or malfunction of any fresenius product(s) or device(s) as reported by a medical professional.Though effluent fluid cultures presented with no growth, an initially elevated wbc count with a reduction of symptoms in response to antibiotic therapy provides evidence of a resolving peritonitis.Therefore, the liberty select cycler with the liberty cycler set can be excluded as a root cause or contributor to this patient¿s adverse event.Based on the available information, there was no allegation or objective evidence of any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

A peritoneal dialysis nurse (pdrn) for a peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support for assistance and during the call the pdrn reported the patient was having draining issues.During the call the pdrn reported that the patient was released from the hospital and has peritonitis.Upon follow up, the pdrn stated they are familiar with the patient who was hospitalized on (b)(6) 2023 following abdominal pain, malaise, chills and cloudy peritoneal effluent fluid.The pdrn reported peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2023 presented with no growth in the culture and a wbc count of 207/mm3.The pdrn stated the patient was diagnosed with peritonitis due to unknown etiology.The pdrn explained the patient complained of fibrin and slow drains requiring heparin on (b)(6) 2023; however, it could not be confirmed whether the slow drains during pd therapy were due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s), or if this event was related to the peritonitis infection.The pdrn reported the patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg every 5 days for two weeks and ip ceftazidime at 1000 mg daily for two weeks.The pdrn stated the patient was able to undergo continuous cyclic pd (ccpd) therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The pdrn stated the patient had an uneventful hospital course and was discharged to home on (b)(6) 2023.The pdrn reported that follow up peritoneal effluent fluid cultures taken in the outpatient clinic on (b)(6) 2023 presented with no growth.The pdrn stated the patient is recovering from this event as they remain asymptomatic on antibiotic therapy.The pdrn confirmed there was no indication or credible evidence this patient¿s adverse event was due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).The pdrn stated the patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

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.

Event Description

A peritoneal dialysis nurse (pdrn) for a peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support for assistance and during the call the pdrn reported the patient was having draining issues.During the call the pdrn reported that the patient was released from the hospital and has peritonitis.Upon follow up, the pdrn stated they are familiar with the patient who was hospitalized on (b)(6) 2023 following abdominal pain, malaise, chills and cloudy peritoneal effluent fluid.The pdrn reported peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2023 presented with no growth in the culture and a wbc count of 207/mm3.The pdrn stated the patient was diagnosed with peritonitis due to unknown etiology.The pdrn explained the patient complained of fibrin and slow drains requiring heparin on (b)(6) 2023; however, it could not be confirmed whether the slow drains during pd therapy were due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s), or if this event was related to the peritonitis infection.The pdrn reported the patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg every 5 days for two weeks and ip ceftazidime at 1000 mg daily for two weeks.The pdrn stated the patient was able to undergo continuous cyclic pd (ccpd) therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The pdrn stated the patient had an uneventful hospital course and was discharged to home on (b)(6) 2023.The pdrn reported that follow up peritoneal effluent fluid cultures taken in the outpatient clinic on (b)(6) 2023 presented with no growth.The pdrn stated the patient is recovering from this event as they remain asymptomatic on antibiotic therapy.The pdrn confirmed there was no indication or credible evidence this patient¿s adverse event was due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).The pdrn stated the patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: 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
• 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: 16587929
• MDR Text Key: 311736899
• Report Number: 0008030665-2023-00297
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87216
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 102 KG