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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
Catalog Number RTLR180343
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Peritonitis (2252); Malaise (2359); Constipation (3274)
Event Date 12/20/2023
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between peritoneal dialysis utilizing the liberty select cycler and liberty cycler set and the patient event of peritonitis with hospitalization.However, there is no documentation to show a causal relationship between the peritonitis event and use of the liberty select cycler and liberty cycler set.Additionally, there is no allegation of a device malfunction or deficiency, or cycler set defect reported for this event.The culture was negative for growth; therefore, the cause of the peritonitis event cannot be confirmed.However, the suspected cause of the peritonitis was reported as constipation.Constipation and diarrhea have been positively correlated with pd-associated peritonitis, suggesting that the presence of diarrhea or constipation increases the risk for pd-associated peritonitis.It has been reported that peritonitis can be caused by transmural migration of intestinal microbes.Furthermore, this patient was new to pd therapy and could have experienced a breach in aseptic technique leading to the peritonitis event.All dialysis patients are at risk of peritonitis due to a compromised immune system and the increase of potential for microbial contamination from dialysis techniques.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 event.
 
Event Description
During follow-up for an unrelated cycler alarm that occurred during this patient¿s peritoneal dialysis (pd) treatment on (b)(6) 2023, it was reported by the patient that they went to the emergency room (er) due to feeling sick.No further details were provided by the patient.Additional follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was admitted to the hospital with a diagnosis of peritonitis.The patient was admitted to the hospital on (b)(6) 2023 due to unspecified symptoms and was diagnosed with peritonitis and constipation.A pd effluent culture was obtained.The patient was administered antibiotic therapy with intraperitoneal (ip) vancomycin (dose, frequency, and duration unknown).The patient¿s white blood cell (wbc) count was elevated to 800 (unknown units).The pd cultures resulted negative for growth; however, initially it was thought the peritonitis would be a gram-negative infection based on the patient¿s concomitant constipation.The patient was discharged on (b)(6) 2023 and continues to complete antibiotic therapy during recovery.The patient is reportedly new to pd therapy.The cause of the patient¿s peritonitis could not be determined.
 
Event Description
During follow-up for an unrelated cycler alarm that occurred during this patient¿s peritoneal dialysis (pd) treatment on (b)(6) 2023, it was reported by the patient that they went to the emergency room (er) due to feeling sick.No further details were provided by the patient.Additional follow-up with the patient¿s pd registered nurse (pdrn) confirmed the patient was admitted to the hospital with a diagnosis of peritonitis.The patient was admitted to the hospital on (b)(6) 2023 due to unspecified symptoms and was diagnosed with peritonitis and constipation.A pd effluent culture was obtained.The patient was administered antibiotic therapy with intraperitoneal (ip) vancomycin (dose, frequency, and duration unknown).The patient¿s white blood cell (wbc) count was elevated to 800 (unknown units).The pd cultures resulted negative for growth; however, initially it was thought the peritonitis would be a gram-negative infection based on the patient¿s concomitant constipation.The patient was discharged on (b)(6) 2023 and continues to complete antibiotic therapy during recovery.The patient is reportedly new to pd therapy.The cause of the patient¿s peritonitis could not be determined.
 
Manufacturer Narrative
Plant investigation: the device was not 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.
 
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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 Key18508517
MDR Text Key332868408
Report Number0002937457-2024-00075
Device Sequence Number1
Product Code FKX
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 Nurse
Type of Report Initial,Followup
Report Date 02/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received02/07/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2015
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; LIBERTY CYCLER SET; LIBERTY CYCLER SET
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age72 YR
Patient SexFemale
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