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

Catalog Number RTLR180343

Device Problem Device Issue (2379)

Patient Problem Hypoglycemia (1912)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.An investigation of the device manufacturing records was conducted and verified that there were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, a device history records (dhr) review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.A clinical review was performed to identify the necessity of performing a clinical investigation for the reported incident.The patient was admitted to the hospital for hypoglycemia due to non-adherence to his diabetic regimen.The patient admitted to not following proper self-care management for his diabetes and pd therapy.Based on the provided information, there is currently no indication of a serious injury, patient death, or other adverse event related to a fresenius product.There is currently no allegation or documentation that suggests that a fresenius device or product caused or contributed to the patient¿s hospitalization.As there is currently no causal relationship between the patient¿s hospitalization and their peritoneal dialysis therapy, a clinical investigation is not warranted.Should additional information become available, the need for a clinical investigation will be reevaluated.

Event Description

It was reported that a patient was hospitalized for hypoglycemia coincident with peritoneal dialysis therapy.While in the hospital it was discovered that the patient had not taken their insulin for the past three days and that they were non-compliant with their regimen for diabetes.Although the cause was attributed to the patient¿s non-adherence to their diabetes regimen, it was alleged that the cycler had not been working well and resulted in the patient not being able to complete full treatments on the cycler.Additional information related to the potential malfunction of the cycler was not provided.It was reported that the patient¿s blood glucose levels quickly stabilized during the hospitalization.The patient was discharged from the hospital after three days and has continued with peritoneal dialysis therapy without complication.

• Brand Name: LIBERTY SELECT 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: 7393721
• MDR Text Key: 104248664
• Report Number: 2937457-2018-00947
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2012
• 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
• Patient Age: 61 YR
• Patient Weight: 90