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 04/03/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: there is a temporal relationship between pd therapy utilizing the liberty select cycler and the patient going to the hospital for a drain.However, there is no documentation to show a causal relationship between the drain complication and the liberty select cycler.The cycler messaged the patient with patient line blocked messages which indicates the patient is draining too slowly.The patient is new to apd and there are several reasons for drain complications including peritoneal membrane failure, pd catheter issues and constipation.The patient was being treated with laxatives and heparin.It is unknown if the patient received any medical intervention at the hospital.The patient refused to troubleshoot the issue with technical support.Despite the fact it being reported that radiology stated there was no pd catheter issue, that was not confirmed by the pdrn.Although there was no reported malfunction and the cycler alerted to a drain complication as designed, based on the limited information and no completed product investigation, it cannot be concluded if the liberty select cycler caused or contributed to the patient¿s hospital visit to drain.

Event Description

It was reported that peritoneal dialysis (pd) patient was admitted to the hospital due to cycler draining issues.Upon follow up, technical support contacted the patient¿s peritoneal dialysis registered nurse (pdrn) who confirmed that this has been an ongoing issue with this patient.The patient was new to automated peritoneal dialysis (apd), the patient had been prescribed laxatives and administered heparin to the solution bags.The patient underwent a pd catheter manipulation with radiology; however, the notes from a call from the patient contact indicated that radiology confirmed no issue with the pd catheter.The pdrn did not have documentation from radiology to confirm.The pdrn was advised to discontinue the use of their cycler, a replacement cycler was issued.The pdrn acknowledged that the replacement would most likely not resolve the patient drain issues and stated she would continue to work with the patient.Attempts to obtain additional information were unsuccessful.

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.

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.A simulated therapy with reduced dwell times was initiated and completed on the cycler without complication.The cycler underwent system air leak, teach pump, and valve actuation testing and was found to meet product specifications.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: 10055770
• MDR Text Key: 190924317
• Report Number: 2937457-2020-00853
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• 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: 05/04/2020
• Device Age: MO
• Date Manufacturer Received: 06/03/2020
• 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