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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Model Number 180343
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Fatigue (1849); 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 patient¿s 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) patient¿s 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 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
Correction: h6.
 
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 1/may/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: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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.
 
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Brand Name
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
MDR Report Key11864077
MDR Text Key252012645
Report Number2937457-2021-01096
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861102068
UDI-Public00840861102068
Combination Product (y/n)N
PMA/PMN Number
K181108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup
Report Date 06/09/2021
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 Number180343
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 05/07/2021
Initial Date FDA Received05/21/2021
Supplement Dates Manufacturer Received05/26/2021
06/04/2021
06/04/2021
Supplement Dates FDA Received06/02/2021
06/09/2021
06/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET 
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age80 YR
Patient Weight90
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