FREEDOM CYCLER SET, 5 LEAD 5-L PEDIATRIC CYCLER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-24 for FREEDOM CYCLER SET, 5 LEAD 5-L PEDIATRIC CYCLER manufactured by Fresenius Medical Care North America.

Event Text Entries

[4877590] The following was based on medical records provided by the patient's treatment facility. The patient was hospitalized on (b)(6) 2014 through (b)(6) 2014 due to bacterial and fungal peritonitis. The patient was treated with a 14 day course of cefepime and fluconazole ip.
Patient Sequence No: 1, Text Type: D, B5


[12348660] The patient was admitted to the hospital on (b)(6) 2014 through (b)(6) 2014 after his mother reported a one day history of cloudy, purulent effluent peritoneal dialysis (pd) fluid. The patient was hospitalized on (b)(6) 2014 through (b)(6) 2014 due to bacterial and fungal peritonitis. During this time, he completed a 14 day course of cefepime and fluconazole intra-peritoneally (ip) through his dialysate. On (b)(6) 2014 his effluent pd fluid cultures were positive for enterobacter cloacae and klebsiella pneumoniae. On (b)(6) 2014 and (b)(6) 2014, pd fluid cultures were positive. The following was based on medical records provided by the patient's treatment facility. He completed a 14 day course of cefepime and fluconazole intraperitoneally (ip). The patient has a history of emesis which has worsened recently as well as baseline loose and frequent stools. The patient was negative for fever and chills. The patient's abdomen was non-tender with no rebound tenderness or guarding. There were normal bowel sounds. His gastrostomy tube site was clean and dry and his pd catheter showed no signs of inflammation. The patient received his last dose of fluconazole in his pd fluid on (b)(6) 2014 and did not start his fluconazole via his gastrostomy tube until (b)(6) 2014. The patient's last positive fungal culture in the pd fluid was on (b)(6) 2014 growing candida famata. His last positive bacterial culture of the pd fluid was on (b)(6) 2014. A supplemental report will be submitted upon completion of the plant's investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8030665-2014-00574
MDR Report Key4016934
Report Source05,06
Date Received2014-07-24
Date of Report2014-06-24
Date of Event2014-04-20
Date Mfgr Received2014-06-24
Date Added to Maude2014-08-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactTANYA TAFT, RN, CNOR
Manufacturer Street920 WINTER STREET
Manufacturer CityWALTHAM MA 02451
Manufacturer CountryUS
Manufacturer Postal02451
Manufacturer Phone7816999000
Manufacturer G1ERIKA DE REYNOSA, S.A. DE C.V.
Manufacturer StreetMIKE ALLEN 1331 PARQUE INDUSTRIAL REYNOSA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFREEDOM CYCLER SET, 5 LEAD 5-L PEDIATRIC CYCLER
Product CodeKPF
Date Received2014-07-24
Lot Number13BR08880
Device Expiration Date2016-02-01
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFRESENIUS MEDICAL CARE NORTH AMERICA
Manufacturer AddressREYNOSA MX


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2014-07-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.