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

Catalog Number RTLR180111

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

Patient Problems Edema (1820); Encephalopathy (1833); Hypoxia (1918); Pleural Effusion (2010); Pneumonia (2011); Weakness (2145); Electrolyte Imbalance (2196); Respiratory Failure (2484); Confusion/ Disorientation (2553); Hypervolemia (2664)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient's clinic registered nurse (rn) reported the pd patient had been hospitalized from (b)(6) 2017 due to fluid overload.Additional information and medical records were requested.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis (pd) patient's clinic registered nurse (rn) reported the pd patient had been hospitalized from (b)(6) 2017 to (b)(6) 2017 due to fluid overload.Additional information and medical records were requested.

Manufacturer Narrative

Date of event: (b)(6) 2017 conclusion: review of the medical records were reviewed and concluded there is a probable temporal relationship associated with the patient¿s altered mental status, generalized weakness, uremia, acute hypoxic respiratory failure, bilateral pleural effusions in lieu of volume overload with new oxygen requirements, necessitating addition of daytime supplement oxygen in addition to the patient¿s nocturnal oxygen requirements, and the subsequent inpatient hospitalization which required a change in the patient¿s pd treatments/adjustment of dialysate strength in accordance with blood pressure monitoring, fluid volume monitoring and improved planned control over blood gas results-specifically oxygen levels and the fresenius products exists.Additionally the patient has highly complex high acuity co-morbidities which may be contributory to this hospitalization with multifactorial complexities.The patient remains a full code status and was discharged in improved clinical condition with ongoing medical and nephrology management.There were no reported allegations.

Event Description

Received medical records were reviewed by a post market surveillance clinician.The peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cycler-assisted peritoneal dialysis (ccpd) therapy required admission to the hospital on (b)(6) 2017 presenting with bilateral pleural effusions on chest x-ray imaging with pro brain natriuretic peptide of greater than 70,000 and additionally with the following diagnoses, disorders of mineral metabolism, hypertension, status post cholesterol gallstones and cancer of gallbladder with stable ejection fraction of 50-55% with previously inserted permanent pacemakers, pleural effusions, anemia, hypertension, lower limb ulcer, hypothyroidism, diabetes mellitus (insulin dependent), chronic secondary hyperparathyroidism hospital acquired pneumonia.The primary active patient problem was esrd with acute hypoxic respiratory failure in lieu of volume overload and new oxygen requirement.The patient was evaluated by nephrology and identified as not a good candidate for hemodialysis (hd) and continued to receive pd exchanges and treatments with prescribed 2.5% dextrose, low calcium additionally ensuring her blood pressure and fluid volume status is acceptable during this hospitalization requiring daytime oxygen supplementation as well as nocturnal oxygen (baseline at home) in order to have improved control of blood gases in lieu of acute hypoxic respiratory failure and current bilateral pleural effusions on imaging.The patient underwent evaluation of the metabolic encephalopathy which was secondary to development of ensuing uremia in the setting of esrd and failed pd, and the patient was actively receiving pd as ordered in the hospital (question adjustments of dialysate strength as noted above) with noted improvement in mental status.Nephrologist recommended the patient to transition to hd, but the patient declined and received intermittent dextrose 50% solutions intravenously (iv) on unknown dates.On (b)(6) 2017 the last documented physical exam occurring on the day of discharge and point system evaluation was as follows: benign except for pulmonary decreased breath sounds in the right lower field and left lower filed ( x-rays noted bilateral pleural effusions), mental status had improved and the patient was now alert and oriented to name and place.The patient was a full code status during this hospitalization was discussed with the patient¿s husband.The patient was seen by nephrology to continue pd as hd therapy not a realistic option due to patient¿s cardiac issues/status.The plan of care for the patient was discussed with the husband and nephrology continued to follow the patient outpatient and the primary care physician continued post discharge wound care for an ulcer.Podiatry was evaluated on consult and determined no acute intervention.On (b)(6) 2017 the patient was medically/nephrology/podiatry cleared for discharge and was noted to be in stable condition with follow-up appointment at the pd clinic scheduled for (b)(6) 2017 and follow up appointment for further wound care.

• 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: 6695828
• MDR Text Key: 79350352
• Report Number: 2937457-2017-00561
• 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: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2017
• 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?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2010
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR