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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number UNKNOWN- FMC CASSETTE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Peritonitis (2252)
Event Date 06/19/2017
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer.A supplemental report will be filed upon completion of the manufacturer's investigation.
 
Event Description
A peritoneal dialysis patient reported that the cycler displayed a drain complication and was unable to bypass.The patient set up with new supplies.During a follow up phone call to the patient's nurse, it was reported that the patient got peritonitis on (b)(6) 2017 and was given a 14 day treatment of fortaz in his solution.The culture was taken and the results showed (acinetobacter baumannii).The patient was able to complete treatment the time of the call after contacting the rn.She assisted the patient with completing with medicated solution without further issues.The patient is still recovering.
 
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 non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.
 
Event Description
A peritoneal dialysis patient reported that the cycler displayed a drain complication and was unable to bypass.The patient set up with new supplies.During a follow up phone call to the patient's nurse, it was reported that the patient got peritonitis on (b)(6) 2017 and was given a 14day traetment of fortaz in his solution.The culture was taken and the results showed (acinebacter baumanni).The patient was able to complete treatment the time of the call after contacting the rn.She assisted the patient with completing with medicated solution without further issues.The patient is still recovering.
 
Manufacturer Narrative
Clinical evaluation: there is no documentation that shows a causal relationship between the event of peritonitis and the liberty cycler.Additionally, there is no allegation against any fresenius products and the event.
 
Event Description
A peritoneal dialysis patient reported that the cycler displayed a drain complication and was unable to bypass.The patient set up with new supplies.During a follow up phone call to the patient's nurse, it was reported that the patient got peritonitis on (b)(6) 2017 and was given a 14day traetment of fortaz in his solution.The culture was taken and the results showed (acinebacter baumanni).The patient was able to complete treatment the time of the call after contacting the rn.She assisted the patient with completing with medicated solution without further issues.The patient is still recovering.
 
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Brand Name
LIBERTY CYCLER SET
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX  88780
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX   88780
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key6852797
MDR Text Key85439275
Report Number8030665-2017-00666
Device Sequence Number1
Product Code FKC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 01/31/2018
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 NumberUNKNOWN- FMC CASSETTE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Device Age MO
Event Location Home
Initial Date Manufacturer Received 06/29/2017
Initial Date FDA Received09/08/2017
Supplement Dates Manufacturer Received10/13/2017
07/14/2017
Supplement Dates FDA Received11/11/2017
01/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
LIBERTY CYCLER; PD FLUID
Patient Outcome(s) Required Intervention;
Patient Age54 YR
Patient Weight107
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