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 Anemia (1706); Urinary Tract Infection (2120)

Event Date 06/16/2019

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 adverse events of urinary tract infection (uti) and anemia, which warranted hospitalization.The patient¿s past medical history includes end stage renal disease (esrd), therefore the diagnosis of renal failure (rf) is extraneous information.The etiology of the events is unknown; therefore, causality cannot definitively be determined.The pdrn stated the hospitalization was unrelated to any fresenius product(s), and no objective evidence exists indicating a liberty select cycler product deficiency or malfunction caused the adverse events.Even so, the liberty select cycler cannot be excluded as having a possible contributory role in the adverse events.The manufacturer investigation of the suspect device is pending.The discharge summary is unavailable and the patient missed a total of 4 days of pd therapy due to cycler alarms.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 fresenius technical support to request a replacement liberty cycler because the cycler was reverting back to the ready screen during setup.The fresenius technical support representative issued a replacement cycler to resolve the problem and advised the pdrn to discontinue using the machine.Upon follow up, the pdrn reported that the patient was hospitalized on (b)(6) 2019 for renal failure (rf), low hemoglobin (anemia) and a urinary tract infection (uti).The patient¿s nursing facility (residence) staff reportedly encountered multiple unspecified liberty select cycler alarms on (b)(6) 2019, nevertheless they were able to complete treatment.However, on (b)(6) 2019 the patient was unable to undergo pd therapy due to the same unspecified cycler alarms.A replacement cycler was delivered on (b)(6) 2019, and the nursing facility staff encountered the same unspecified alarms.As such, the patient was unable to receive pd therapy again on (b)(6) 2019.The pdrn instructed the staff to flush the pd catheter (not a fresenius product), which was performed without difficulty, however due to additional unspecified liberty select cycler alarms, the patient was unable to receive pd therapy on (b)(6) 2019.The pdrn attempted to bring the patient to the outpatient dialysis clinic, however transportation could not be arranged, and the patient was sent to the emergency department.The hospital course is unknown, as the discharge summary was not available.The pdrn stated that the patient was discharged back to the nursing facility, and has transitioned to a baxter cycler, at the nephrologist¿s request.Per the pdrn, the hospitalization was unrelated to the liberty select cycler or any fresenius products.Subsequent attempts to obtain additional information have thus far proven unsuccessful.

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.A voltage test passed.During the evaluation encountered a stalled at a state machine for a long time warning.The cycler underwent and failed a system air leak test due to a bad crimp found on the seven manifold cable valve 21 causing pressure not to build.Replaced seven valve manifold cable with new cable and pressure now builds.The valve actuation test and teach pumps passed.A post-accelerated stress test (ast) 2hours 15mins 8500ml simulated treatment was performed without any failures or problems.An internal visual inspection of the returned cycler encountered no discrepancies.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, a stalled at a state machine for a long time warning occurred which confirmed the reported (unspecified alarm) and the system air leak test failed due to a bad crimp found on the seven manifold cable valve 21.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event 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: 8746757
• MDR Text Key: 149627689
• Report Number: 2937457-2019-02030
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Device Age: MO
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 06/29/2019
• Supplement Dates Manufacturer Received: 08/14/2019
• Supplement Dates FDA Received: 08/23/2019
• 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: 62 YR
• Patient Weight: 73