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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 LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2018
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant¿s investigation.
 
Event Description
A peritoneal dialysis patient reported receiving scale reading errors to technical services.Treatment data was provided.Treatment data was assessed for 150% and 180% iipv and did reveal an episode of increased intraperitoneal volume (iipv).The largest drain volume from this treatment occurred on (b)(6) 2018 during drain 4 where 4576ml drained.This drain is 228% of the prescribed fill volume.In order to be a reportable malfunction, at least 180% of the prescribed fill volume would have to have been drained.180% of fill volume 2005ml is 3609ml.Therefore, a reportable malfunction has occurred.Patient was advised to discontinue use of the cycler and contact the clinic nurse.Additional information was solicited.
 
Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no sign of physical damage.A simulated treatment was performed and completed on the cycler with no issues noted.The load cell verification was performed and passed.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.The cycler weighed fill volume values were within tolerance.There were no discrepancies encountered in the internal inspection of the cycler.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, 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.
 
Event Description
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Event Description
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Manufacturer Narrative
Correction: returned to manufacturer on 2018-05-04.
 
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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 Key7503850
MDR Text Key107977951
Report Number2937457-2018-01298
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,Followup
Report Date 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberLIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2018
Device AgeMO
Initial Date Manufacturer Received 04/29/2018
Initial Date FDA Received05/10/2018
Supplement Dates Manufacturer Received05/04/2018
05/23/2018
Supplement Dates FDA Received05/22/2018
06/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LIBERTY CYCLER SET; PD SOLUTION
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