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 Low Blood Pressure/ Hypotension (1914); Uremia (2188)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler, and the patient¿s hospitalization for uremia and hypotension.Per the pdrn, the cause of the uremia was non-compliance, as the patient skipped several days of pd therapy.However, repeated drain complications and ¿patient line is blocked¿ alarms frustrated the patient, which drove the non-compliance.Per the pdrn, the patient¿s pd catheter (not a fresenius product) works appropriately when performing manual pd therapy.Non-compliance is a major contributing factor when considering the efficacy of pd therapy.The patient¿s hypotension is a chronic problem and existed prior to the initiation of pd therapy.While there is no objective evidence indicating a liberty select cycler product deficiency or malfunction caused the patient¿s adverse events; the liberty select cycler cannot be excluded from having a possible contributory role.Given the pdrn¿s allegation, a pending manufacturer evaluation and no alarm history/treatment data, there is insufficient evidence to disassociate the liberty select cycler.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A peritoneal dialysis registered nurse (pdrn) contacted technical support to report a patient line is blocked (soft alarm) that was occurring on a patient¿s liberty select cycler.The pdrn stated that there was a small amount of fibrin present.Upon follow up, the pdrn stated that the patient had been hospitalized due to issues with uremia and low blood pressure.The pdrn stated that the patient was non-complaint and ¿skipped¿ pd therapy for several days (dates not provided), causing the uremia.The pdrn stated that the patient¿s non-compliance was driven by the patient¿s frustration with repeated liberty select cycler alarms (e.G.Drain complications and/or patient line is blocked).The patient¿s non-compliance and missed treatments were just uncovered on (b)(6) 2019.The patient was encountering multiple ¿red¿ alarms and contacted the on-call pdrn for assistance.However, when the patient continued to experience the alarms, they became uncomfortable using the liberty select cycler and decided to not perform any renal replacement therapy (rrt).The pdrn stated that something must be wrong with the cycler, as the patient does well with manual therapy.The pdrn stated that the patient¿s hypotension has been a chronic issue since beginning rrt.The patient started rrt on hemodialysis (hd); however, the patient¿s baseline blood pressure was 70/40, and would drop to unsafe levels during hd.The nephrologist and patient decided to try pd therapy, however the pdrn stated it is undecided if the transition was beneficial or not.The patient remains hospitalized and will be trialing a baxter cycler while hospitalized.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.An (as-received) simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.The cycler underwent and passed a system air leak test and valve actuation test.The load cell verification was within tolerance.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; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8955113
• MDR Text Key: 158610591
• Report Number: 2937457-2019-02802
• 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
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• 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: 09/16/2019
• Device Age: MO
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR