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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING LIBETY 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 Fever (1858); Pneumonia (2011)
Event Date 05/13/2017
Event Type  Injury  
Manufacturer Narrative
The liberty cycler was not returned to the plant for investigation.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 record review confirmed the labeling, material, and process controls were within specification.A supplemental report will be submitted upon completion of the clinical investigation.
 
Event Description
Peritoneal dialysis nurse reported that a peritoneal dialysis patient was hospitalized on (b)(6) 2017 with a fever.Follow up with the patient's peritoneal dialysis nurse indicated that the patient was diagnosed and treated for pneumonia.The source of the infection is unknown.The patient continues to performed peritoneal dialysis at the hospital.Additional information was solicited.
 
Manufacturer Narrative
The liberty cycler was not returned to the plant for investigation.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 record review confirmed the labeling, material, and process controls were within specification.A supplemental report will be submitted upon completion of the clinical investigation.Conclusion: although a temporal relationship exists between the liberty cycler/fresenius products and the patient¿s probable respiratory symptoms, fever episodes and subsequent development of pneumonia requiring hospitalization, there is no allegation against any fresenius products and the association of the patient¿s pneumonia and subsequent hospitalization.
 
Event Description
Review of the complaint file was completed by a post market surveillance clinician.It was reported this peritoneal dialysis (pd) patient reported drain complications from fibrin present in the pd catheter, which were resolved with heparin instillation.On (b)(6) 2017 during a follow up call to the pd patient¿s clinic registered nurse (rn), it was revealed the patient was performing pd treatments and started experiencing fevers of unknown etiology requiring the patient to be admitted on (b)(6) 2017.Additionally, the patient continued to perform pd treatments during febrile episode.On (b)(6) 2017 during a follow up call to the service center the patient contact stated the patient was experiencing drain complications during drain 0 of 4 with 111/1500ml drained.The patient contact stated stat drained the patient but the drain was very slow.The patient contact opted to cancel treatment and followed up with pd clinic in the morning.The pd patient stated he had no problems with ccpd treatment on night of (b)(6) 2017 and the patient decided to cancel treatment for night of (b)(6) 2017 and go to pd clinic for a schedule appointment on (b)(6) 2017.The issue of the drain complications was resolved with standard of care heparin secondary to fibrin issues in the pd catheter.During the hospitalization the patient continued to perform pd treatments, as yet peritonitis is not confirmed.On (b)(6) 2017, during a follow up call the pdrn revealed the patient continued to be hospitalized (currently 9 days length of stay) for pneumonia with fever episodes.
 
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Brand Name
LIBETY 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 Key6614371
MDR Text Key76745530
Report Number2937457-2017-00432
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861100972
UDI-Public00840861100972
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 health professional,user faci
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/22/2017
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 05/16/2017
Initial Date FDA Received06/06/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2013
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
PD SOLUTION
Patient Outcome(s) Hospitalization; Required Intervention;
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