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 Death (1802); Pneumonia (2011); Pulmonary Edema (2020); Uremia (2188); Hypervolemia (2664)

Event Date 11/19/2017

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 contact stated the patient was hospitalized from (b)(6) 2017 due to pneumonia, fluid build-up in his lungs, and uremia.The contact stated while hospitalized a temporary access catheter was placed for the patient to complete hemodialysis treatments while hospitalized due to the patient¿s uremia.The patient¿s contact stated after discharge her husband was able to complete peritoneal dialysis treatment using the cycler on (b)(6) 2017.The patient¿s contact stated the patient suffered from leukemia, and indicated the patient¿s leukemia doctor examined the patient after briefly being discharged on (b)(6) 2017 and stated the patient still had fluid in the his lungs, and was to go back to the hospital on (b)(6) 2017.The patient¿s contact stated the patient was-admitted to the hospital on (b)(6) 2017 and as of (b)(6) 2017 was still hospitalized.The patient¿s contact stated the patient did not have any history of pneumonia or issues related to chronic obstructive pulmonary disease (copd) in the past.Medical records were requested.

Manufacturer Narrative

Brand name: liberty select cycler assy(non-valuated), catalog: rtlr180343, unique identifier (udi): (b)(4), occupation: lay user / (b)(4).Conclusion: there is no documentation that shows a causal relationship between the events of, pneumonia, fluid build-up in lungs, uremia, the hospitalization or the subsequent death of the patient and the liberty cycler.There is no allegation against any fresenius device(s) and the adverse events.No hospital records were received, and both the hospital course of events are unknown.Additionally, it is unknown if the patient was using any fresenius products during the hospitalization.According to the nurse the patient had been hospitalized many times over the past year related to his cancer.It is unknown how contributory the leukemia or if there were other comorbidities that may have been a factor in the course of events.At this time any possible causality cannot be determined based on the lack of information provided.Additional information related to the patients¿ demographics, medical and surgical history, comorbidities, hospital courses, labs, medical testing, concomitant medical products, death certificate and/or autopsy report is needed to determine potential causality.Plant investigation: 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-conformance 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

Information in the complaint file was reviewed by a post market surveillance clinician.On (b)(6) 2017 it was reported by the patients¿ contact (wife) that this male, end stage renal disease (esrd) patient utilizing continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized (hospital course unknown) from (b)(6) 2017 due to pneumonia, fluid build-up in his lungs, and uremia.According to the patient¿s wife during the hospitalization a temporary access catheter was placed for hemodialysis (hd) treatments (details unknown) for the uremia.Reportedly the patient was discharged and was able to complete ccpd treatment on (b)(6) 2017.However, according to the patient¿s wife the patient and a history of leukemia (details unknown); went to see his ¿leukemia doctor¿ and upon examination the physician determined the patient still had fluid in his lungs and sent the patient back to the hospital on (b)(6) 2017 at which time was readmitted to the hospital (hospital course unknown).On 12/15/2017 during a follow up call to the patient¿s pdrn, it was learned the patient expired on (b)(6) 2017; the details of the patient expiration were unknown.Although the pdrn stated the patient was a cancer patient, and had many hospitalizations over the year.But, did not give any details regarding hospitalizations.The pdrn stated that the clinic did not have a death certificate and the cause of death was unknown at this time.

• 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
• 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: 7080768
• MDR Text Key: 93654126
• Report Number: 2937457-2017-01286
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• 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?: No
• Device Age: MO
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2015
• 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
• Treatment: LIBERTY CYCLER; PD SOLUTION
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention