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

Catalog Number 050-87216

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

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 01/25/2024

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse (pdrn) reported that the patient is a bedbound patient and was not hospitalized but visited the emergency room (er) on 8 march 2024.The patient was experiencing hypotension for some time and was being treated with midodrine medication.The pdrn confirmed that none of the events were related to the pd therapy or the use of fresenius products.She stated that the patient was doing well and continuing with pd treatment.While on the call, the pdrn stated that the patient was hospitalized in february for peritonitis, but she had no further information about the event.Upon follow up, it was reported this patient was hospitalized on 25/jan/2024 following abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on 26/jan/2024 presented with no growth in the culture and a wbc count of 612/mm3.The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg and ip ceftazidime at 2000 mg (frequency and duration not reported) to address the infection.It was believed the patient was able to undergo ccpd therapy on a hospital provided cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on 2/feb/2024.It was confirmed, though the exact cause of this adverse event remains unknown, there was no indication the patient¿s peritonitis, and the associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event as he remains asymptomatic and continues ccpd therapy on the same liberty select cycler at home post-discharge.

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 liberty cycler set and the adverse event of peritonitis, characterized by abdominal pain.It is well established that pd patients are at high risk for infections of the peritoneum.The cause of this adverse event remains unknown; however, there was no indication the patient¿s peritonitis, and the associated hospitalization were 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 no growth, an initially elevated wbc count with decreasing symptoms in response to antibiotic therapy provides evidence of a resolving peritonitis infection.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 registered nurse (pdrn) reported that the patient is a bedbound patient and was not hospitalized but visited the emergency room (er) on 8 march 2024.The patient was experiencing hypotension for some time and was being treated with midodrine medication.The pdrn confirmed that none of the events were related to the pd therapy or the use of fresenius products.She stated that the patient was doing well and continuing with pd treatment.While on the call, the pdrn stated that the patient was hospitalized in february for peritonitis, but she had no further information about the event.Upon follow up, it was reported this patient was hospitalized on 25/jan/2024 following abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on 26/jan/2024 presented with no growth in the culture and a wbc count of 612/mm3.The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg and ip ceftazidime at 2000 mg (frequency and duration not reported) to address the infection.It was believed the patient was able to undergo ccpd therapy on a hospital provided cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on 2/feb/2024.It was confirmed, though the exact cause of this adverse event remains unknown, there was no indication the patient¿s peritonitis, and the associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event as he remains asymptomatic and continues ccpd therapy on the same liberty select cycler at home post-discharge.

Manufacturer Narrative

Correction: c, h6 device component code, filled in blank values 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.

Manufacturer Narrative

Correction: c, h6 device component code, filled in blank values 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 registered nurse (pdrn) reported that the patient is a bedbound patient and was not hospitalized but visited the emergency room (er) on (b)(6) 2024.The patient was experiencing hypotension for some time and was being treated with midodrine medication.The pdrn confirmed that none of the events were related to the pd therapy or the use of fresenius products.She stated that the patient was doing well and continuing with pd treatment.While on the call, the pdrn stated that the patient was hospitalized in february for peritonitis, but she had no further information about the event.Upon follow up, it was reported this patient was hospitalized on (b)(6) 2024 following abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2024 presented with no growth in the culture and a wbc count of 612/mm3.The patient was diagnosed with peritonitis due to unknown etiology.The patient was prescribed intraperitoneal (ip) vancomycin at 2000 mg and ip ceftazidime at 2000 mg (frequency and duration not reported) to address the infection.It was believed the patient was able to undergo ccpd therapy on a hospital provided cycler for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.It was confirmed, though the exact cause of this adverse event remains unknown, there was no indication the patient¿s peritonitis, and the associated hospitalization were due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event as he remains asymptomatic and 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: 18997300
• MDR Text Key: 338886931
• Report Number: 0008030665-2024-00312
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/15/2024
• 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; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 86 KG