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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 Stroke/CVA (1770); Myocardial Infarction (1969); Pulmonary Edema (2020)
Event Date 06/05/2021
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.Furthermore, it is unknown if the patient was in treatment at the time of the event.There are no reported issues with the liberty select cycler prior to the hospitalization on (b)(6) 2021.
 
Event Description
On (b)(6) 2021 a patient contact for a peritoneal dialysis (pd) patient contacted fresenius technical support for a drain complication.The patient contact stated the patient was just recently hospitalized with fatigue.Follow-up information was provided through the patient¿s contact.The patient was hospitalized on (b)(6) 2021 due to a myocardial infarction, stroke, and fluid in the lungs.The patient was discharged on (b)(6) 2021.Additional follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn) only yielded information that the patient was being transitioned to hemodialysis (hd) at the request of the family due to caregiver burn-out.Attempts to obtain further details were unsuccessful.
 
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
On (b)(6) 2021 a patient contact for a peritoneal dialysis (pd) patient contacted fresenius technical support for a drain complication.The patient contact stated the patient was just recently hospitalized with fatigue.Follow-up information was provided through the patient¿s contact.The patient was hospitalized on (b)(6) 2021 due to a myocardial infarction, stroke, and fluid in the lungs.The patient was discharged on (b)(6) 2021.Additional follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn) only yielded information that the patient was being transitioned to hemodialysis (hd) at the request of the family due to caregiver burn-out.Attempts to obtain further details were unsuccessful.
 
Event Description
On (b)(6) 2021 a patient contact for a peritoneal dialysis (pd) patient contacted fresenius technical support for a drain complication.The patient contact stated the patient was just recently hospitalized with fatigue.Follow-up information was provided through the patient¿s contact.The patient was hospitalized on (b)(6) 2021 due to a myocardial infarction, stroke, and fluid in the lungs.The patient was discharged on (b)(6) 2021.Additional follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn) only yielded information that the patient was being transitioned to hemodialysis (hd) at the request of the family due to caregiver burn-out.Attempts to obtain further details were unsuccessful.
 
Manufacturer Narrative
Correction: h6.
 
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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 Key12167055
MDR Text Key261525514
Report Number2937457-2021-01478
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 consumer
Type of Report Initial,Followup,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
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
Date Manufacturer Received07/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET 
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