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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
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2018
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 to technical support a high drain volume during drain 1 of the peritoneal dialysis treatment.Treatment data was provided.Treatment data was assessed for 150% and 180% iipv and did reveal an episode of increased intraperitoneal volume (iipv) on (b)(6) 2018.The largest drain volume from this treatment occurred on during drain 1 where 3679ml drained.This drain is 184% 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.A 180% of fill volume 2000ml is 3600.Therefore, a reportable malfunction has occurred.The patient was advised to discontinue use of the cycler and contact the clinic nurse.Follow up with the clinic nurse confirmed the patient did not experience any complications as a result of the alleged event.The patient does perform a manual exchange during the day.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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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
Manufacturer (Section G)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7503759
MDR Text Key108264609
Report Number2937457-2018-01301
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861102068
UDI-Public00840861102068
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 06/13/2018
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
Device Catalogue NumberRTLR180343
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2018
Is the Reporter a Health Professional? No
Device AgeMO
Initial Date Manufacturer Received 05/06/2018
Initial Date FDA Received05/10/2018
Supplement Dates Manufacturer Received06/06/2018
Supplement Dates FDA Received06/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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