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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
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.
 
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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 Key6537287
MDR Text Key74196390
Report Number2937457-2017-00310
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123630
Number of Events Reported1
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 NumberRTLR180111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 04/03/2017
Initial Date FDA Received05/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/31/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
FMC CASSETTE; PD SOLUTIONS
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age53 YR
Patient Weight109
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