MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abdominal Distention (2601)

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between continuous cyclical peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler, and the patient¿s adverse event(s) of bloating, abdominal pain and/or a tearing feeling which warranted a decrease in the patient¿s fill volume.The manufacturer evaluation/investigation of the liberty select cycler was pending at the time of this investigation.Given the concurrent relationship shared by the events, and no established cause, the liberty select cycler cannot be disassociated from having a possible contributory role in the events.End stage renal disease (esrd) patients are known to commonly experience gastrointestinal and abdominal complications (both infectious and non-infectious) for a variety of reasons.

Event Description

A peritoneal dialysis registered nurse (pdrn) contacted fresenius technical support to report the liberty select cycler has been powering down during treatment.The nurse was advised to discontinue use of the cycler and a new cycler was issued to the patient.Upon follow-up, the pdrn stated that the patient was able to complete treatment on the cycler and has received the new cycler.The pdrn stated that the patient was experiencing pain in the lower right abdominal region and was feeling full.The pdrn stated that per a surgeon's recommendation, the patient prescribed fill volume was changed from 2000 ml to 1500 ml.The patient has since been feeling well since the fill volume change.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed no signs of physical damage.Although there were visual indications of dried fluid within the cassette compartment, there were no visual indications of particulates within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.The simulated treatment was performed and completed without any failures or problems.The cycler underwent and passed a load cell verification check, valve actuation test, system air leak test, and voltage verification check.An internal visual inspection of the returned cycler encountered no other discrepancies.The glucose test strip tested positive.There were no discrepancies encountered with the mushroom heads.A device history review (dhr) was performed and found a failed hipot test and sent to rework.The rework hipot test failed and no power.The power module was replaced, and power was restored.The cycler was also sent back to test and calibration.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.

• 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 Key: 8557192
• MDR Text Key: 143386480
• Report Number: 2937457-2019-01216
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Device Age: MO
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention