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 Problem Peritonitis (2252)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) - there was no information provided that indicated a causal relationship between the peritoneal dialysis and use of fresenius products and the peritonitis.The most common cause of peritonitis is a breach in technique or biofilm on the peritoneal dialysis catheter.The actual device was not returned to the manufacturer for physical evaluation.The device serial number has not been made available, as such a review of the device manufacturing records could not be completed.However, a device is not released unless all processes and inspections have been completed.

Event Description

The peritoneal dialysis nurse reported that the patient was admitted to the hospital on (b)(6) 2016 due to peritonitis.Medical records were received from the clinic which showed the (b)(6) peritoneal dialysis patient presented to the emergency room on (b)(6) 2016 with nausea, vomiting, abdominal pain and diarrhea.The patient also noted some weight loss, 7 kg in the past 4 days.Prior to the emergency room visit the patient was seen in the peritoneal dialysis clinic and was started on intraperitoneal cefepime 1 g and cefazolin 2.5 g following a peritoneal effluent culture that tested positive for viridans streptococcus.The patient has been treated with peritoneal dialysis since (b)(6) 2016.The patient was admitted to the hospital for treatment of peritonitis.Repeat fluid analysis on day 2 of admission showed persistent elevation in white blood cell count despite intraperitoneal antibiotics.Intravenous ceftriaxone was added for 3 days and infectious disease was consulted given history of urinary tract infections with failure to improve.The peritoneal fluid cultures grew streptococcus viridans sensitive to ceftriaxone and clindamycin.The intraperitoneal antibiotics were transitioned to ceftriaxone and a repeat fluid analysis on day 5 of admission showed decreased cellularity suggesting improvement, however repeat fluid analysis on day 7 of admission showed increased cellularity.On day 8 of admission fluid analysis results showed improvement, however not at the expected rate.The patient was discharged from the hospital starting intraperitoneal daptomycin for a total of 2 weeks including ceftriaxone form the start date of (b)(6) 2016.

• 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: 6195267
• MDR Text Key: 62998078
• Report Number: 2937457-2016-01249
• 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: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• 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: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 SOLUTION; LIBERTY TUBING
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 122