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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
Catalog Number RTLR180343
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 07/23/2019
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: the file has been assessed for the necessity of performing a clinical investigation on a reported hospitalization.On (b)(6) 2019, this patient on peritoneal dialysis contacted customer and reported she had not used the cycler since (b)(6) 2019 and was currently experiencing a drain line is blocked message with the liberty select cycler.The cycler was processed for replacement during the call.There were no reported issues with any fresenius device or product in relation to the hospitalization during the call.During follow-up, the pd nurse reported the patient¿s hospitalization had nothing to do with any aspect of pd treatment.The nurse declined to provide any additional information.Reportedly, the patient has been completing pd treatments while waiting for the cycler without any reported issues.Currently, there is no allegation or any objective evidence that any fresenius device(s) caused or contributed to a serious adverse patient outcome.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), please re-submit for a clinical investigation review and the need for a clinical investigation will be re-evaluated accordingly.
 
Event Description
A peritoneal dialysis (pd) patient contacted fresenius technical support to report a check drain line message they received.During the call the patient mentioned they had been in the hospital.Upon follow up with the pd nurse, it was reported that the patient¿s hospitalization was not due to any aspect of pd treatment.The nurse declined to provide any additional information.She confirmed the patient has been completing pd treatment.
 
Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.The cycler underwent and passed a system air leak test and a valve actuation test.The 2 hour 15 min 8500 ml simulated treatment was performed and completed without failures.A review of the device manufacturing records was conducted by the manufacturer.A device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.
 
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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
MDR Report Key8892184
MDR Text Key154244191
Report Number2937457-2019-02569
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 09/11/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2019
Device Age MO
Initial Date Manufacturer Received 07/29/2019
Initial Date FDA Received08/14/2019
Supplement Dates Manufacturer Received08/22/2019
Supplement Dates FDA Received09/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DELFLEX PD FLUID; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET
Patient Outcome(s) Hospitalization;
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