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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA NEWTON CYCLER
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FRESENIUS MEDICAL CARE NORTH AMERICA NEWTON CYCLER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Urinary Retention (2119); Obstruction/Occlusion (2422)
Event Date 09/23/2014
Event Type  No Answer Provided  
Event Description
It was reported that a peritoneal dialysis (pd) pt had been hospitalized from(b)(6) 2014 for symptoms of bowel obstruction adn urine retention.The pt underwent a colectomy.
 
Manufacturer Narrative
Per the pt's pdrn, the pt has since transitioned from pd to hemodialysis treatments.The pt has not been diagnosed with hernia.Medical records have been requested to assist the clinical investigation process.Medical records have been requested to assist the clinical investigation process.A supplemental report will be submitted upon completion of plant's investigation.
 
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Brand Name
NEWTON CYCLER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
concord CA
Manufacturer (Section G)
FRESENIUS MEDICAL CARE NORTH AMERICA
4040 nelson ave
concord CA 94520
Manufacturer Contact
tanya taft, rn
920 winter street
waltham, MA 02451
7816999000
MDR Report Key4249662
MDR Text Key5109164
Report Number2937457-2014-03107
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
PMA/PMN Number
K002892
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility
Type of Report Initial
Report Date 10/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received10/08/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2008
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 SOLUTIONS; NEWTON CYCLER CASSETTE
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age73 YR
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