• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Chest Pain (1776); Pain (1994)
Event Date 09/18/2019
Event Type  Injury  
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.Clinical investigation: there is a temporal relationship between pd therapy and the patient event of chest and foot pain during treatment with subsequent hospitalization.However; there is no documentation in the complaint file to show a causal relationship between the patient event and use of the liberty select cycler.The cause of the patient¿s chest pain is unknown, but the patient continues to undergo cardiac studies on an outpatient basis.Cardiovascular disease is a well-known comorbidity in chronic kidney disease with up to 45% of patients already having advanced manifestations of cardiovascular disease when they reach end stage renal disease (esrd).(berthina coleman (md, 2018) the patient returned to utilizing the same liberty select cycler with no additional issues.Based on the information provided and no allegation of a device malfunction or deficiency, the liberty select cycler can be excluded as the cause of the patient¿s hospitalization for chest pain.
 
Event Description
A peritoneal dialysis (pd) patient called in to report they were feeling pain in their chest and feet during pd treatment.The patient cancelled treatment due to the pain.Patient indicated pain was ongoing for the last month.There were no reported alarms on the cycler.Patient¿s treatment details were reviewed and there were no signs of iipv.An occurrence of power fail recovery failed was identified.The patient indicated they had a touch screen problem due to it being out of calibration.Patient refused to calibrate.Patient was advised to follow up with the pd registered nurse.Upon follow up with the pdrn it was reported that they were unaware that the patient had called on the date of the event.The pdrn is unsure if the patient was able to complete treatment.The patient was hospitalized on the date of the patient¿s call, (b)(6) 2019, and admitted due to the alleged chest pain.The pdrn does not have specifics of treatment for chest pain but indicated patient would be undergoing cardiology study on an outpatient basis.Patient continued pd treatment while hospitalized but the type of pd therapy and device are unknown.Patient was discharged on (b)(6) 2019.The cause of the patient¿s chest pain is unknown.The pdrn clarified there was no reason to suspect the patient¿s chest pain and subsequent hospitalization was related to pd therapy nor the use of a fresenius device, drug, or product.The patient is now home, the symptoms have subsided, and he has continued continuous cyclic pd (ccpd) treatment on the same cycler without further issues.Patient has been on pd treatment since (b)(6) 2016.No sample was returned for physical evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
amaral, matthew
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key9152319
MDR Text Key161229759
Report Number2937457-2019-03096
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Device Age MO
Initial Date Manufacturer Received 09/24/2019
Initial Date FDA Received10/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age66 YR
Patient Weight112
-
-