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 Dyspnea (1816); Hypoxia (1918); Pneumonia (2011); Hypervolemia (2664)

Event Date 09/15/2018

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Clinical review: a clinical investigation was performed to identify a causal relationship between the patient's peritoneal dialysis (pd) treatment and the reported acute respiratory failure with hypoxia due to fluid overload and pneumonia.The cause of the pneumonia was documented as community acquired.The etiology of the fluid overload which subsequently led to acute respiratory failure with hypoxia is unknown, therefore causality cannot be established.Based on the information available there is no documentation or indication the liberty select cycler caused or contributed to a serious adverse patient event.Additionally, there is no allegation or evidence of a machine malfunction or of the machine failing to perform as expected in relation to the event.The patient continues to utilize the same liberty select cycler, implying no fresenius product or device involvement.Although a causal relationship cannot be confirmed, a temporal relationship between the patient's pd therapy and the reported event remains.Should additional new information be made available this clinical investigation will be reevaluated.

Event Description

A peritoneal dialysis registered nurse (pdrn) for a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) reported the patient was hospitalized for acute respiratory failure with hypoxia due to fluid volume overload and community acquired pneumonia.The patient¿s discharge summary was reviewed.The patient presented to the emergency room (er) for worsening shortness of breath (sob) for two days.The patient underwent a chest x-ray which indicated pneumonia, and the patient was started on azithromycin and ceftriaxone (dosage, route and frequency unknown) for five days.Additionally the patient was diagnosed with acute respiratory failure with hypoxia due to fluid overload, as evidenced by the removal of 4.4 liters of fluid during the hospitalization.No changes to the patient¿s pd prescription were noted.The patient was discharged home after five days in stable condition, and the pdrn reported the patient has recovered from the event(s).It is unknown if any fresenius device(s) or product(s) were utilized during the hospitalization.

• 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: 7933666
• MDR Text Key: 122640725
• Report Number: 2937457-2018-02936
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/04/2018

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: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2011
• 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: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 107