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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 08/14/2019
Event Type  Injury  
Manufacturer Narrative
Clinical review: based on the information available, the liberty select cycler is disassociated from the event, as there is no allegation or objective evidence indicating a product deficiency or malfunction caused or contributed to the adverse event(s).Furthermore, to our knowledge, the patient continues to utilize the same liberty select cycler without any reported issues or allegations of machine malfunction or deficiency.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
A peritoneal dialysis (pd) patient contacted technical support for assistance with an issue that occurred during step 1 of set up.The patient was not connected.The patient was at the hospital and wanted the phone number of their personal peritoneal dialysis registered nurse (pdrn) so that they could assist the hospital nurse in setting up the hospital cycler.Upon follow up with the health services facility, no record or information regarding the patient could be found.Multiple attempts have been made requesting additional information, however to date have not been received.
 
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.
 
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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 Key8935241
MDR Text Key155655989
Report Number2937457-2019-02745
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861102068
UDI-Public00840861102068
Combination Product (y/n)N
PMA/PMN Number
K171652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 09/12/2019
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 Health Professional
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? No
Device Age MO
Initial Date Manufacturer Received 08/14/2019
Initial Date FDA Received08/27/2019
Supplement Dates Manufacturer Received09/09/2019
Supplement Dates FDA Received09/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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