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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 Dyspnea (1816); Peritonitis (2252); Hypervolemia (2664)
Event Date 05/07/2021
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between pd therapy with the liberty select cycler/liberty cycler set and the patient¿s subsequent hospitalization for fluid volume overload and possible peritonitis.However, there were no reported allegations that the events were related to any issues with fresenius products.Fluid volume overload is not uncommon in patients on dialysis because of the kidney disease process which affects fluid balance in the body.Moreover, non-compliance with dialysis treatments carries significant risk for hospitalization and fluid overload in pd patients.Therefore, the patient¿s fluid volume overload can be reasonably attributed to patient noncompliance from skipping several pd treatments the week prior to event.Moreover, peritonitis is a well-documented complication in patients undergoing pd therapy.The patient¿s pd culture yielded growth of the organism staphylococcus which is an organism that is typically found on human skin and can sometimes be implicated in microbial contamination when collecting/processing cultures.Based on the reported information, it cannot be deciphered if the patient had a true peritonitis infection.The patient had a normal cell count and no reported symptoms consistent with peritonitis infection.It is possible the patient¿s culture yielded growth of the microbe due to a contaminated pd culture or via touch contamination or breach in aseptic technique when handling the pd exchange.
 
Event Description
A peritoneal dialysis (pd) patient contacted fresenius and reported experiencing breathing issues which required hospitalization.The patient reported getting an infection/peritonitis and having fluid in the lungs after their home was exterminated.The patient did not report any allegations that the event was related to fresenius products.In additional follow-up, the patient¿s pd nurse reported that on (b)(6) 2021 the patient began having symptoms of shortness of breath.Subsequently, on (b)(6) 2021, the patient was admitted to the hospital with fluid volume overload.Per the nurse, there were no product issues associated with the fluid overload event.Rather, the nurse stated it was because the patient was non-compliant and had been skipping several pd treatments the week prior.The nurse stated that during the hospitalization, the patient had a pd culture obtained which yielded a normal white blood cell (wbc) count and growth of coagulase negative staphylococcus.It was reported the patient was treated with unknown antibiotics and continued pd therapy.Subsequently, on (b)(6) 2021, the patient was discharged from the hospital.The nurse stated the peritonitis event was not related to any issues with a fresenius device or product.The nurse indicated that a true peritonitis was not suspected.Per the nurse, due to the patient¿s pd culture having a normal cell count and no symptoms of peritonitis, it is likely the pd culture was contaminated during hospitalization.Per the nurse, the patient was not on antibiotic therapy upon discharge and continues pd therapy on the same cycler without any adverse effects.
 
Manufacturer Narrative
Plant investigation: the device was not 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
A peritoneal dialysis (pd) patient contacted fresenius and reported experiencing breathing issues which required hospitalization.The patient reported getting an infection/peritonitis and having fluid in the lungs after their home was exterminated.The patient did not report any allegations that the event was related to fresenius products.In additional follow-up, the patient¿s pd nurse reported that on (b)(6) 2021 the patient began having symptoms of shortness of breath.Subsequently, on (b)(6) 2021, the patient was admitted to the hospital with fluid volume overload.Per the nurse, there were no product issues associated with the fluid overload event.Rather, the nurse stated it was because the patient was non-compliant and had been skipping several pd treatments the week prior.The nurse stated that during the hospitalization, the patient had a pd culture obtained which yielded a normal white blood cell (wbc) count and growth of coagulase negative staphylococcus.It was reported the patient was treated with unknown antibiotics and continued pd therapy.Subsequently, on (b)(6) 2021, the patient was discharged from the hospital.The nurse stated the peritonitis event was not related to any issues with a fresenius device or product.The nurse indicated that a true peritonitis was not suspected.Per the nurse, due to the patient¿s pd culture having a normal cell count and no symptoms of peritonitis, it is likely the pd culture was contaminated during hospitalization.Per the nurse, the patient was not on antibiotic therapy upon discharge and continues pd therapy on the same cycler without any adverse effects.
 
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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 Key12200239
MDR Text Key262635157
Report Number2937457-2021-01522
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 company representative,consum
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
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; LIBERTY CYCLER SET; LIBERTY CYCLER SET
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age46 YR
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