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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE BONDED COMBISETS

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FRESENIUS MEDICAL CARE BONDED COMBISETS Back to Search Results
Model Number 03-2742-9
Device Problem Insufficient Information (3190)
Patient Problem Cardiac Arrest (1762)
Event Date 06/17/2014
Event Type  Injury  
Event Description
It was reported by the dialysis clinic that on (b)(6) 2014 during hemodialysis treatment the pt became short of breath approx four minutes into treatment.Oxygen applied via nasal cannula.By 6 minutes into treatment, pt became unresponsive and arrested.The pt was resuscitated and transported to a local hospital and admitted to the critical care unit.Additional info has been requested.
 
Manufacturer Narrative
This report is being submitted as part of a system level review; if any additional info is obtained, a supplemental report will be submitted.Plant investigation: complaint sample is not available, and the lot number of product involved in this incident is unk.However, a three month sales and shipping search to the client site identified the lots shipped to the site.According tot he sap system no product is available from these lots on distribution centers to be analyzed.The entire lots have been sold and distributed.Dhr review was performed on the identified lots.No nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met current specs.No conclusion can be drawn regarding the complaint without an examination of the product used during the reported event.The event reported on this pt involves six separate products.Medical records review: the pt experienced a cardiac arrest during hemodialysis.This event will be reported as a serious injury, although it is undetermined if there is a reasonable suspected causal relationship between the product(s) and the event of cardiac arrest.There is no history of specific malfunction or products being out of spec.
 
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Brand Name
BONDED COMBISETS
Manufacturer (Section D)
FRESENIUS MEDICAL CARE
reynosa
MX 
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
parque industrial reynosa
reynosa, tamaulipas CP 8 8780
MX   CP 88780
Manufacturer Contact
corrie vazquez, mgr
920 winter st
waltham, MA 02451
7816999071
MDR Report Key4043996
MDR Text Key4802750
Report Number8030665-2014-00565
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/23/2014
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 Health Professional
Device Model Number03-2742-9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/23/2014
Initial Date FDA Received07/23/2014
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
FMC 0/9% SALINE; GRANUFLO; FMC DIALYZER; NATURALYTE; 2008 DIALYSIS SYSTEM
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age64 YR
Patient Weight55
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