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

Model Number 180343

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

Patient Problem No Information (3190)

Event Date 02/04/2020

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 ccpd therapy utilizing the liberty select cycler and the adverse event(s) of hospitalization.The cause of the patient¿s hospitalization is unknown; therefore, causality cannot be established.Per the spouse, the patient¿s medical doctor stated the liberty select cycler is ¿not operating correctly; however, no additional information was provided.Based on the limited information available, the liberty select cycler cannot be excluded from having a possible causal or contributory role in the event(s).Due to the lack of causality, treatment records and discharge summary, there is insufficient evidence to disassociate the liberty select cycler from the event(s).

Event Description

It was reported that a peritoneal dialysis (pd) patient's cycler is not operating correctly.The medical doctor (md) indicated that the patient won't be released from the hospital until the cycler is replaced.The patient contact was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Additional information was requested, however it was not available.Based on the limited information available, the liberty select cycler cannot be excluded from having a possible causal or contributory role in the event(s).Due to the lack of causality, treatment records and discharge summary, there is insufficient evidence to disassociate the liberty select cycler from the event(s).

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.There were no visual indication of particulates.A simulated therapy was initiated and completed on the cycler without complication.The weighed fill volumes were found to be within tolerance and fill times were within specification.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.Load cell verification testing was performed with no issues noted.An internal, visual inspection of the received cycler unit encountered insect infestation.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.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 9706678
• MDR Text Key: 179279355
• Report Number: 2937457-2020-00313
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Device Age: MO
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization