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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 Problem Chest Pain (1776)
Event Date 11/02/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, a call was placed to customer support on behalf of this patient on peritoneal dialysis (pd) requesting assistance with how to cancel the treatment on the fresenius cycler.There were no reported allegations the any issues with the fresenius cycler.However, it was reported the patient was experiencing symptom of chest pain.An additional follow-up call was made to the patient¿s pd nurse who provided the patient was admitted to the hospital on (b)(6) 2022 due to the reported chest pain.The nurse indicated the patient has pre-existing cardiac disease with previous stent placement, atherosclerosis, and recent vasculitis.It was confirmed the event was not related to any issues with fresenius products or related to the pd treatment.Additionally, the nurse stated the patient has been completing pd treatments on the fresenius cycler without any adverse effects prior to the event.The nurse attributed the chest pain to the patient¿s pre-existing comorbid conditions.At the time follow-up was completed, the patient remained hospitalized.The nurse had no further information available.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Manufacturer Narrative
Correction: h10 clinical investigation: a temporal relationship exists between peritoneal dialysis (pd) therapy with the liberty select cycler and the patient¿s chest pain requiring hospitalization.Currently, there have been no reported allegations nor is there objective evidence that a liberty select cycler malfunction or product deficiency was associated with the patient¿s chest pain.Additionally, it was confirmed with the patient¿s pd nurse that the patient was completing pd treatments with the fresenius cycler without any adverse effects.The patient has pre-existing cardiac disease with previous stent placement, atherosclerosis, and recent vasculitis.Based on the available information, the patient¿s chest pain is likely to be associated with this event.
 
Event Description
On 2/nov/2022, a call was placed to customer support on behalf of this patient on peritoneal dialysis (pd) requesting assistance with how to cancel the treatment on the fresenius cycler.There were no reported allegations the any issues with the fresenius cycler.However, it was reported the patient was experiencing symptom of chest pain.An additional follow-up call was made to the patient¿s pd nurse who provided the patient was admitted to the hospital on (b)(6) 2022 due to the reported chest pain.The nurse indicated the patient has pre-existing cardiac disease with previous stent placement, atherosclerosis, and recent vasculitis.It was confirmed the event was not related to any issues with fresenius products or related to the pd treatment.Additionally, the nurse stated the patient has been completing pd treatments on the fresenius cycler without any adverse effects prior to the event.The nurse attributed the chest pain to the patient¿s pre-existing comorbid conditions.At the time follow-up was completed, the patient remained hospitalized.The nurse had no further information available.
 
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) 2022, a call was placed to customer support on behalf of this patient on peritoneal dialysis (pd) requesting assistance with how to cancel the treatment on the fresenius cycler.There were no reported allegations the any issues with the fresenius cycler.However, it was reported the patient was experiencing symptom of chest pain.An additional follow-up call was made to the patient¿s pd nurse who provided the patient was admitted to the hospital on (b)(6) 2022 due to the reported chest pain.The nurse indicated the patient has pre-existing cardiac disease with previous stent placement, atherosclerosis, and recent vasculitis.It was confirmed the event was not related to any issues with fresenius products or related to the pd treatment.Additionally, the nurse stated the patient has been completing pd treatments on the fresenius cycler without any adverse effects prior to the event.The nurse attributed the chest pain to the patient¿s pre-existing comorbid conditions.At the time follow-up was completed, the patient remained hospitalized.The nurse had no further information available.
 
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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 Key15835354
MDR Text Key304030131
Report Number0002937457-2022-02019
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 12/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2022
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? No
Device AgeMO
Date Manufacturer Received12/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/14/2020
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; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET 
Patient Outcome(s) Hospitalization;
Patient Age65 YR
Patient SexMale
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