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); Fatigue (1849); Muscle Weakness (1967); Electrolyte Imbalance (2196); Peritonitis (2252); Confusion/ Disorientation (2553)

Event Date 05/01/2021

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 continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty cycler set and the adverse events of peritonitis (characterized by abdominal pain and cloudy effluent fluid) and urinary tract infection (characterized by confusion, weakness, and hyperkalemia), which warranted hospitalization and antibiotic therapy.The etiology of the serious adverse events is unknown; therefore, causality cannot be firmly established.However, the peritoneal dialysis registered nurse (pdrn) reported the serious adverse events were not the result of a fresenius device(s) and/or product(s) deficiency or malfunction.The patients cognition has been worsening lately and the pdrn feels this is a contributing factor.Peritonitis with no identifiable organism occurs in approximately 1/5 of all peritonitis cases.As such, alternative markers such as abdominal pain, elevated cell count and/or cloudy effluent fluid must serve as indicators.Based on the information available, the liberty select cycler and liberty cycler set can be disassociated from the events.There is no objective evidence indicating a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the serious adverse events experienced by the patient.End stage rendal dialysis (esrd) patients undergoing pd therapy are known to be at high risk for infections of the peritoneum.

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) since (b)(6) 2020, was discharged from the hospital on (b)(6)2021 (no additional information provided during intake).Follow-up with the patients pd registered nurse (pdrn) revealed the patient presented to the emergency room (er) on (b)(6) 2021 with cloudy peritoneal effluent fluid, abdominal pain, hyperkalemia, weakness and confusion.A peritoneal effluent fluid culture and cell count (wbc elevated, >20,000 u/l) was collected, and the patient was diagnosed with peritonitis.Additionally, a urinalysis revealed the patient had a severe urinary tract infection (uti), which was the root cause of the patients hyperkalemia, confusion, and weakness.The patient was started on intraperitoneal (ip) cefazolin and ceftazidime daily (dose, duration not provided).The peritoneal effluent culture result was negative for growth on (b)(6) 2021, and the patients antibiotics were continued.The patient was discharged home on (b)(6) 2021 and is recovering from the events.Per the pdrn, the patient resumed utilizing the same liberty select cycler as before the events.No follow-up cell count or peritoneal effluent fluid culture has been collected.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.Although the cause is unknown, the patient is elderly and the pdrn feels recent cognitive deficits contributed to the events.

Manufacturer Narrative

Correction: h3, d10, h6.

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) since (b)(6) 2020 , was discharged from the hospital on (b)(6) 2021 (no additional information provided during intake).Follow-up with the patient¿s pd registered nurse (pdrn) revealed the patient presented to the emergency room (er) on (b)(6) 2021 with cloudy peritoneal effluent fluid, abdominal pain, hyperkalemia, weakness and confusion.A peritoneal effluent fluid culture and cell count (wbc elevated, >20,000 u/l) was collected, and the patient was diagnosed with peritonitis.Additionally, a urinalysis revealed the patient had a severe urinary tract infection (uti), which was the root cause of the patient¿s hyperkalemia, confusion, and weakness.The patient was started on intraperitoneal (ip) cefazolin and ceftazidime daily (dose, duration not provided).The peritoneal effluent culture result was negative for growth on (b)(6) 2021 and the patient¿s antibiotics were continued.The patient was discharged home on (b)(6) 2021 and is recovering from the events.Per the pdrn, the patient resumed utilizing the same liberty select cycler as before the events.No follow-up cell count or peritoneal effluent fluid culture has been collected.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.Although the cause is unknown, the patient is elderly and the pdrn feels recent cognitive deficits contributed to the events.

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) since (b)(6) 2020, was discharged from the hospital on (b)(6) 2021 (no additional information provided during intake).Follow-up with the patient¿s pd registered nurse (pdrn) revealed the patient presented to the emergency room (er) on (b)(6) 2021 with cloudy peritoneal effluent fluid, abdominal pain, hyperkalemia, weakness and confusion.A peritoneal effluent fluid culture and cell count (wbc elevated, >20,000 u/l) was collected, and the patient was diagnosed with peritonitis.Additionally, a urinalysis revealed the patient had a severe urinary tract infection (uti), which was the root cause of the patient¿s hyperkalemia, confusion, and weakness.The patient was started on intraperitoneal (ip) cefazolin and ceftazidime daily (dose, duration not provided).The peritoneal effluent culture result was negative for growth on (b)(6) 2021, and the patient¿s antibiotics were continued.The patient was discharged home on (b)(6) 2021 and is recovering from the events.Per the pdrn, the patient resumed utilizing the same liberty select cycler as before the events.No follow-up cell count or peritoneal effluent fluid culture has been collected.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.Although the cause is unknown, the patient is elderly and the pdrn feels recent cognitive deficits contributed to the events.

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 (pd) patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) since (b)(6) 2020, was discharged from the hospital on (b)(6) 2021 (no additional information provided during intake).Follow-up with the patient¿s pd registered nurse (pdrn) revealed the patient presented to the emergency room (er) on (b)(6) 2021 with cloudy peritoneal effluent fluid, abdominal pain, hyperkalemia, weakness and confusion.A peritoneal effluent fluid culture and cell count (wbc elevated, >20,000 u/l) was collected, and the patient was diagnosed with peritonitis.Additionally, a urinalysis revealed the patient had a severe urinary tract infection (uti), which was the root cause of the patient¿s hyperkalemia, confusion, and weakness.The patient was started on intraperitoneal (ip) cefazolin and ceftazidime daily (dose, duration not provided).The peritoneal effluent culture result was negative for growth on (b)(6) 2021, and the patient¿s antibiotics were continued.The patient was discharged home on (b)(6)2021 and is recovering from the events.Per the pdrn, the patient resumed utilizing the same liberty select cycler as before the events.No follow-up cell count or peritoneal effluent fluid culture has been collected.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.Although the cause is unknown, the patient is elderly and the pdrn feels recent cognitive deficits contributed to the events.

Manufacturer Narrative

Correction: h10 in follow up #2 included a correction made to sections d10 and h3.This was performed inadvertently.No corrections were made to sections d10 and h3.

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) since 10/aug/2020, was discharged from the hospital on (b)(6) 2021 (no additional information provided during intake).Follow-up with the patient¿s pd registered nurse (pdrn) revealed the patient presented to the emergency room (er) on (b)(6) 2021 with cloudy peritoneal effluent fluid, abdominal pain, hyperkalemia, weakness and confusion.A peritoneal effluent fluid culture and cell count (wbc elevated, >20,000 u/l) was collected, and the patient was diagnosed with peritonitis.Additionally, a urinalysis revealed the patient had a severe urinary tract infection (uti), which was the root cause of the patient¿s hyperkalemia, confusion, and weakness.The patient was started on intraperitoneal (ip) cefazolin and ceftazidime daily (dose, duration not provided).The peritoneal effluent culture result was negative for growth on (b)(6) 2021, and the patient¿s antibiotics were continued.The patient was discharged home on 6/may/2021 and is recovering from the events.Per the pdrn, the patient resumed utilizing the same liberty select cycler as before the events.No follow-up cell count or peritoneal effluent fluid culture has been collected.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.Although the cause is unknown, the patient is elderly and the pdrn feels recent cognitive deficits contributed to the events.

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) since (b)(6) 2020, was discharged from the hospital on (b)(6) 2021 (no additional information provided during intake).Follow-up with the patient¿s pd registered nurse (pdrn) revealed the patient presented to the emergency room (er) on (b)(6) 2021 with cloudy peritoneal effluent fluid, abdominal pain, hyperkalemia, weakness and confusion.A peritoneal effluent fluid culture and cell count (wbc elevated, >20,000 u/l) was collected, and the patient was diagnosed with peritonitis.Additionally, a urinalysis revealed the patient had a severe urinary tract infection (uti), which was the root cause of the patient¿s hyperkalemia, confusion, and weakness.The patient was started on intraperitoneal (ip) cefazolin and ceftazidime daily (dose, duration not provided).The peritoneal effluent culture result was negative for growth on (b)(6) 2021, and the patient¿s antibiotics were continued.The patient was discharged home on (b)(6) 2021 and is recovering from the events.Per the pdrn, the patient resumed utilizing the same liberty select cycler as before the events.No follow-up cell count or peritoneal effluent fluid culture has been collected.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.Although the cause is unknown, the patient is elderly and the pdrn feels recent cognitive deficits contributed to the events.

• 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
• MDR Report Key: 11864188
• MDR Text Key: 254514725
• Report Number: 8030665-2021-00905
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/14/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 050-87216
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 05/27/2021; 06/04/2021; 06/04/2021; 06/04/2021; 06/10/2021
• Supplement Dates FDA Received: 06/02/2021; 06/09/2021; 06/09/2021; 06/09/2021; 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 90