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 Pulmonary Embolism (1498); Abdominal Pain (1685); Fever (1858); Pneumonia (2011); Sepsis (2067); Tachycardia (2095); Peritonitis (2252)

Event Date 04/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although there is a temporal relationship between the ccpd treatment with fresenius cycler on (b)(6) 2017 and the reported adverse events of the not feeling well during ccpd therapy with early treatment termination, abdominal pain, fever and the subsequent hospitalization on (b)(6) 2017 for reported adverse events there is no documentation in the records that indicates there is a causal relationship between the adverse events and subsequent hospitalization and the liberty cycler.However, there is a probable association with the patient's presenting symptoms, hospitalization and the admitting diagnoses of sepsis, gout, pulmonary emboli, ascites, hematemesis, extended-spectrum beta-lactamases (esbl) e-coli infection.Additionally, there is no allegations against any fresenius product and reported adverse events.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.

Event Description

During a follow up call for an unrelated event a dialysis nurse stated that the patient was hospitalized due to experiencing abdominal pain, fever, and hypotension while in treatment on (b)(6) 2017.The patient was presented with tachycardia, hematemesis, and hypotension.Patient was administered normal saline, transferred to the intensive care unit for further management.At some point, the patient also underwent computerized tomography (ct) of the chest which confirmed pneumonia.The patient was started on zosyn and vancomycin for possible spontaneous bacterial peritonitis.The patient continued with peritoneal dialysis therapy while hospitalized.Additional admitting diagnosis included sepsis, gout, pulmonary emboli, ascites, hematemesis, extended-spectrum beta-lactamases e-coli infection; treatment and hospital course for these diagnosis is unknown.On (b)(6) 2017 the patient was discharged home in a stable condition on renal diet, medications, with follow up appointments, continuing ccpd therapy.The patient stated that he's allergic to shellfish and they had gone out to eat seafood earlier in the night to which he attributed the event.The patient continued peritoneal dialysis therapy while hospitalized.

• 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: 6537287
• MDR Text Key: 74196390
• Report Number: 2937457-2017-00310
• Device Sequence Number: 1
• Product Code: FKX
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/02/2017

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: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2009
• 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: FMC CASSETTE; PD SOLUTIONS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 109