MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Device Issue (2379)

Patient Problem Hypervolemia (2664)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.A temporal relationship exist between the patients¿ ccpd treatment, the reported sb line blockage resulting in the need for a stat drain, and the liberty cycler.However, it is unknown if a relationship exist between the hospitalization, complaint of not being unable to walk and creatinine levels being ¿very high¿ and the liberty cycler.It is also unknown if a causal relationship exist between the reported fluid retention and the liberty cycler.There is however a possible association with the patients¿ need for rrt transition from pd to hd and the reported elevation of creatinine levels and fluid retention.

Event Description

It was reported this end stage renal disease (esrd) patient on continuous cyclic peritoneal dialysis (ccpd) therapy for renal replacement therapy (rrt) for approximately 2 months was admitted to the hospital on (b)(6) 2017.The patient had reportedly called into customer service during ccpd treatment on (b)(6) 2017 with complaints of ¿dwell 4/5 46 minutes remaining with supply bag (sb) lines are blocked¿.With customer service assistance the patient cancelled ccpd treatment and did a stat drain.During a follow up call to the patient it was learned that the patient ¿went to the hospital the same morning due to not being able to walk¿ (details unknown).The patient stated in the emergency room (er) lab work performed determined that the patients¿ creatinine level was very high (lab value unknown).The patient also disclosed that during the hospitalization she had transitioned to hemodialysis (hd).On (b)(6) 2017 a call to the patient pd registered nurse (rn) confirmed the patients¿ hospital admission.At that time it was learned that the patient was admitted to the hospital for fluid retention and had transitioned to hd.The pdrn stated the patient was currently being care for in a rehabilitation facility and did not have hospital discharge date or any details related to the hospitalization.Additionally, the pdrn stated the discharge summary was not available.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6843945
• MDR Text Key: 84933680
• Report Number: 2937457-2017-00833
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 65 YR