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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 Pneumonia (2011); Peritonitis (2252)
Event Date 05/17/2017
Event Type  Injury  
Manufacturer Narrative
A follow up mdr will be submitted upon completion of the plant's investigation.
 
Event Description
A peritoneal dialysis patient called to reported drain complication alarms.The patient mentioned that she is currently in the hospital for infection around her catheter and pneumonia.Patient stated that she had seen fibrin, pink and red stuff.A follow up call was made to the patient's nurse who reported that the patient was in the hospital for peritonitis.The nurse did not recall the admission date or discharge date.Additional information has been solicited.
 
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.Although a temporal association exists between fresenius products and the event of hospitalization, peritonitis and pneumonia; there is no documentation that indicates a causal relationship between fresenius products and stated adverse events.Furthermore, there are no reported allegations against any fresenius products and the events of hospitalization, peritonitis and pneumonia.Unknown course of hospitalization/ treatment for peritonitis and pneumonia event, therefore unable to determine causality.Should additional new information be made available this clinical investigation will be reevaluated.
 
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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 Key6637008
MDR Text Key77439167
Report Number2937457-2017-00452
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 consumer,health professional
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 07/19/2017
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? No
Device AgeMO
Initial Date Manufacturer Received 05/17/2017
Initial Date FDA Received06/13/2017
Supplement Dates Manufacturer Received06/26/2017
Supplement Dates FDA Received07/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2010
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
DELFLEX PD SOLUTION; LIBERTY TUBING
Patient Outcome(s) Hospitalization; Required Intervention;
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