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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Model Number LIBERTY CYCLER
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pneumonia (2011)
Event Date 02/04/2018
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer.A supplemental report will be filed upon completion of the manufacturer's investigation.
 
Event Description
A peritoneal dialysis patient reported receiving the heater bag not detected message and a not enough supply bags for total treatment message during treatment.The patient stated being at the hospital and using a hospital cycler.Upon follow up with the hospital dialysis unit it was reported that the patient was hospitalized from (b)(6) 2018 for pneumonia.
 
Manufacturer Narrative
Device:the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.Clinical: the file has been assessed (including a review of 18 pages of medical records received on 23/feb/2018) for the necessity of performing a clinical investigation.On (b)(6) 2018, this (b)(6) male patient (pt.) on continuous cycling peritoneal dialysis went to the hospital experiencing flu-like symptoms and was admitted to the hospital with a diagnosis of mycoplasma pneumonia, bacteremia and sepsis.The pt.Also had a discharge diagnosis of hyponatremia however the pt¿s sodium was within normal range at hospital discharge.Details surrounding the pt¿s medical management during hospitalization are unknown.The pt.Appears to have been continuing pd therapy on a hospital cycler while hospitalized.The pt.Was discharged home on (b)(6)2018.Based on the available information in the file, there is no allegation against or documentation that suggests that any fresenius device(s) or product(s) caused or contributed to the pt¿s event of mycoplasma pneumonia, bacteremia, sepsis and hyponatremia.Therefore, the completion of a clinical investigation is not warranted at this time.Should additional information become available regarding a serious adverse event experienced by a patient and/or user related to a fresenius device(s) and/or product(s), the need for a clinical investigation will be re-evaluated accordingly.
 
Event Description
A peritoneal dialysis patient reported receiving the heater bag not detected message and a not enough supply bags for total treatment message during treatment.The patient stated being at the hospital and using a hospital cycler.Upon follow up with the hospital dialysis unit it was reported that the patient was hospitalized from (b)(6) 2018 to (b)(6) 2018 for pneumonia.
 
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Brand Name
LIBERTY CYCLER
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
MDR Report Key7292438
MDR Text Key100795054
Report Number2937457-2018-00591
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861100972
UDI-Public00840861100972
Combination Product (y/n)N
PMA/PMN Number
K123630
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberLIBERTY CYCLER
Device Catalogue NumberRTLR180111
Was Device Available for Evaluation? No
Device AgeMO
Event Location Hospital
Date Manufacturer Received02/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LIBERTY CYCLER SET; PD FLUID; LIBERTY CYCLER SET; PD FLUID
Patient Age47 YR
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