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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 01/14/2023
Event Type  Injury  
Event Description
On 14/jan/2023, a contact for this peritoneal dialysis (pd) patient contacted fresenius technical support to inquire about a stat drain.The patient was in dwell 1 of 3 and experiencing chest pain.The contact wanted to do a stat drain to take the patient to the hospital.The contact was provided information.Attempts to obtain additional information were unsuccessful.
 
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 and the patient event of chest pain as the patient was in active treatment at the time.However, there is no documentation in the complaint file to show a causal relationship between the chest pain and need to go to the hospital and use of the liberty select cycler.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.It is unknown if the patient has any cardiac history which could have caused the chest pain.Patients on pd have a high prevalence of various cardiovascular complications including coronary artery disease, arrhythmia, and heart failure.Furthermore, it is unknown if the patient received any medical intervention at the hospital.Based on the available information and no allegation or evidence of a device malfunction, the liberty select cycler can be excluded as the cause of the patient¿s chest pain during treatment.
 
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 14/jan/2023, a contact for this peritoneal dialysis (pd) patient contacted fresenius technical support to inquire about a stat drain.The patient was in dwell 1 of 3 and experiencing chest pain.The contact wanted to do a stat drain to take the patient to the hospital.The contact was provided information.Attempts to obtain additional information were unsuccessful.
 
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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 Key16273620
MDR Text Key308495803
Report Number0002937457-2023-00141
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2023
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 Received01/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2019
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; LIBERTY CYCLER SET ; LIBERTY CYCLER SET 
Patient Outcome(s) Hospitalization;
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