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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER UL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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CONCORD MANUFACTURING LIBERTY CYCLER UL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number UNKNOWN- LIBERTY CYCLER UL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pneumonia (2011)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
In a customer experience survey, an anonymous patient on incenter hemodialysis reported having had pneumonia while previously on peritoneal dialysis modality, products unknown.Additionally, it was reported the patient had a several holes in the diaphragm which allowed the peritoneal dialysis solution/exchange to leak into lungs.No additional information can be obtained about the event due to this being an anonymous patient.However, there were no recorded allegations, nor any objective evidence of these events being caused by a fresenius device or product malfunction, deficiency, or otherwise product related issue.Therefore, the completion of a clinical investigation is not warranted at this time the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
During a customer experience survey, it was reported that a patient was on peritoneal dialysis (pd) therapy and became sick with pneumonia.The patient reported they had large holes in their diaphragm that allowed the dextrose solution to leak into their lungs.The patient had to immediately return to hemodialysis (hd) following the event.Attempts to obtain additional information could not be completed as there is no patient contact information in which to follow-up.
 
Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, a product history review was not completed during the investigation as the serial number was not provided.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached.Investigation determined that there was no causal relationship between the objective evidence and the alleged event; the alleged event is unconfirmed.
 
Event Description
During a customer experience survey, it was reported that a patient was on peritoneal dialysis (pd) therapy and became sick with pneumonia.The patient reported they had large holes in their diaphragm that allowed the dextrose solution to leak into their lungs.The patient had to immediately return to hemodialysis (hd) following the event.Attempts to obtain additional information could not be completed as there is no patient contact information in which to follow-up.
 
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Brand Name
LIBERTY CYCLER UL
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 Key14803199
MDR Text Key295039453
Report Number0002937457-2022-01041
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123630
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 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN- LIBERTY CYCLER UL
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
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