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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 Sepsis (2067); Peritonitis (2252); Malaise (2359)
Event Date 06/16/2022
Event Type  Death  
Event Description
On (b)(6) 2022 a contact for this female peritoneal dialysis (pd) patient reported that the patient passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in active pd treatment on the liberty select cycler on (b)(6) 2022 when they began not feeling well (unspecified).The patient was transported to the hospital and admitted for sepsis related to peritonitis.During the hospitalization, the pd catheter was pulled.The patient passed away in the hospital on (b)(6) 2022.The cause of the peritonitis is unknown.No further information related to the hospitalization, peritonitis, or death were available.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: there is a temporal relationship between peritoneal dialysis (pd) therapy utilizing the liberty select cycler with cycler set and the patient event of peritonitis complicated by sepsis and subsequent death.However, there is no documentation in the complaint file to show a causal relationship between the use of the liberty select cycler with cycler set and the adverse event.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for this event.The cause of the patient¿s peritonitis is unknown.All dialysis treatments include risk of infection due to the compromised immune system of the patients and dialysis techniques increasing the potential for microbial contamination.Infection is the second leading cause of death in patients with end stage renal disease (esrd) in which septicemia accounts for 75% of this category.This patient population is considered at high-risk for the development of lethal sepsis.There is no documentation stating that the patient sought medical intervention for the peritonitis prior to being admitted to the hospital with sepsis.It is also unknown if the patient had underlying comorbid conditions that contributed to the death.Based on the available information and no allegation or evidence of a malfunction, deficiency, or defect, the liberty select cycler and liberty cycler set can be excluded as the cause of the patient¿s peritonitis with subsequent sepsis and death.
 
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-conformance's, 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
On 13/jul/2022, a contact for this female peritoneal dialysis (pd) patient reported that the patient passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in active pd treatment on the liberty select cycler on (b)(6) 2022 when they began not feeling well (unspecified).The patient was transported to the hospital and admitted for sepsis related to peritonitis.During the hospitalization, the pd catheter was pulled.The patient passed away in the hospital on (b)(6) 2022.The cause of the peritonitis is unknown.No further information related to the hospitalization, peritonitis, or death were available.
 
Manufacturer Narrative
Correction: b5.
 
Event Description
On 13/jul/2022 a contact for this female peritoneal dialysis (pd) patient reported that the patient passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in active pd treatment on the liberty select cycler on (b)(6) 2022 when they began not feeling well (unspecified).The patient was transported to the hospital and admitted for sepsis related to peritonitis.During the hospitalization, the pd catheter was pulled.The patient passed away in the hospital on (b)(6) 2022.The cause of the peritonitis is unknown.It was confirmed that the patient passed away from complications of the infection.No further information related to the hospitalization, peritonitis, or death were available.
 
Event Description
On 13/jul/2022 a contact for this female peritoneal dialysis (pd) patient reported that the patient passed away.Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn).The patient was in active pd treatment on the liberty select cycler on (b)(6) 2022 when they began not feeling well (unspecified).The patient was transported to the hospital and admitted for sepsis related to peritonitis.During the hospitalization, the pd catheter was pulled.The patient passed away in the hospital on (b)(6) 2022.The cause of the peritonitis is unknown.It was confirmed that the patient passed away from complications of the infection.No further information related to the hospitalization, peritonitis, or death were available.
 
Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.The cycler underwent and passed a system air leak test, valve actuation test, go no go check, and load cell verification.An as-received simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.The cycler was able to complete the treatment without issues.There were no visual discrepancies encountered during the internal inspection.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the leak event is confirmed due to the presence dried fluid within the device, which is indicative of fluid contact.There were no malfunctions found during testing that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.
 
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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
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key15143314
MDR Text Key297028324
Report Number0002937457-2022-01281
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861102068
UDI-Public00840861102068
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2022
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? Device Returned to Manufacturer
Device AgeMO
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
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 
Patient Outcome(s) Hospitalization; Death;
Patient Age75 YR
Patient SexFemale
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