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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 Hypervolemia (2664)
Event Date 09/21/2022
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a tear or opening in the abdominal lining known as a pleuroperitoneal leak can cause dialysate to leak from the abdominal cavity into the thorax resulting in fluid filling the heart and lungs.Pleuroperitoneal leak is uncommon but significant complication of pd and thought to be increased intra-abdominal pressure in the presence of an underlying congenital or acquired diaphragmatic defect.
 
Event Description
On 21/sep/2022 a peritoneal dialysis registered nurse [(pd)rn] spoke with fresenius technical support regarding continued drain issues this pd patient was encountering on the liberty select cycler.The patient was receiving draining slowly messages.The patient could complete treatment utilizing the clinic cycler without issue.No fibrin was visible, and the patient was not constipated.The patient was fluid overloaded and drained 2.5l of fluid at the hospital and another 2.5l at the clinic.Upon follow-up with the pdrn, it was noted that initially when the patient began reporting the drain complications, multiple troubleshooting techniques were tried as well as a clinical assessment of the patient.The patient tried a combination of 2.5% and 4.25% solution to pull off more fluid (standing order).They also added heparin to the solution (standing order).The patient underwent a kub showing proper placement of the pd catheter tip and no constipation.The patient had 2.5l of fluid drained at the pd clinic on (b)(6) 2022.On (b)(6) 2022 the patient went to the emergency room (er) and was found to be fluid overloaded.The patient had a chest x-ray which showed excess fluid in the lungs.The patient underwent a thoracentesis removing an additional 2.5l of fluid.The patient was not admitted to the hospital.The patient was ordered a replacement liberty select cycler; however, the drain issues continued with the new cycler.It is suspected that the patient has a pleuroperitoneal leak, but the hospital does not have the capability to test for this anatomical defect.The patient will undergo another thoracentesis and then be placed on back-up hemodialysis (hd) for one week to see if the fluid overload issue resolves.If the condition does not re-occur, the patient will be diagnosed with a pleuroperitoneal leak.The pdrn stated that the patient¿s fluid overload is not related to the liberty select cycler or other fresenius products.
 
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 21/sep/2022 a peritoneal dialysis registered nurse [(pd)rn] spoke with fresenius technical support regarding continued drain issues this pd patient was encountering on the liberty select cycler.The patient was receiving draining slowly messages.The patient could complete treatment utilizing the clinic cycler without issue.No fibrin was visible, and the patient was not constipated.The patient was fluid overloaded and drained 2.5l of fluid at the hospital and another 2.5l at the clinic.Upon follow-up with the pdrn, it was noted that initially when the patient began reporting the drain complications, multiple troubleshooting techniques were tried as well as a clinical assessment of the patient.The patient tried a combination of 2.5% and 4.25% solution to pull off more fluid (standing order).They also added heparin to the solution (standing order).The patient underwent a kub showing proper placement of the pd catheter tip and no constipation.The patient had 2.5l of fluid drained at the pd clinic on (b)(6) 2022.On (b)(6) 2022 the patient went to the emergency room (er) and was found to be fluid overloaded.The patient had a chest x-ray which showed excess fluid in the lungs.The patient underwent a thoracentesis removing an additional 2.5l of fluid.The patient was not admitted to the hospital.The patient was ordered a replacement liberty select cycler; however, the drain issues continued with the new cycler.It is suspected that the patient has a pleuroperitoneal leak, but the hospital does not have the capability to test for this anatomical defect.The patient will undergo another thoracentesis and then be placed on back-up hemodialysis (hd) for one week to see if the fluid overload issue resolves.If the condition does not re-occur, the patient will be diagnosed with a pleuroperitoneal leak.The pdrn stated that the patient¿s fluid overload is not related to the liberty select cycler or other fresenius products.
 
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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 Key15531308
MDR Text Key301084465
Report Number0002937457-2022-01644
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 Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 11/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number180343
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received10/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2010
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;
Patient Age38 YR
Patient SexFemale
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