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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE COMBI SET

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FRESENIUS MEDICAL CARE COMBI SET Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802)
Event Date 01/16/2013
Event Type  Death  
Event Description
The following is based on the medical records provided by the patient's attorney.The plaintiff's attorney alleged that the decedent experienced a cardiovascular event and subsequently expired on (b)(4) 2013, after the use of the product.
 
Manufacturer Narrative
This report is being submitted as part of a system level review: plant investigation: complaint sample is not available, and the lot number of product involved in this incident is unknown.However, a three month sales and shipping search to the client site demonstrated 7 lots.According to the sap system no product is available from these lots on distribution centers to be analyzed.The entire lots have been sold and distributed.Device history records review was performed on potential related lots.No nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met current specifications.A search was conducted in pilgrim complaints system, no add'l complaints with the same symptom code were found for any of the potential related lots.Medical records info reviewed: this event has been reported as a serious injury, although it is undetermined if there is a reasonable suspected causal relationship between the product(s) and the event.There is no history of specific malfunction or product being out of specifications.The allegations of serious injury remain speculative in nature.The event reported on this patient involves six separate products and associated with mdr's 2937457-2014-01145, 1713747-2014-00315, 2937457-2014-00499, 1225714-2014-00513, 1225714-2014-00514, and 1713747-2014-99980.
 
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Brand Name
COMBI SET
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 8878 0
MX   88780
Manufacturer Contact
corie vazquez, manager
920 winter street
waltham, MA 02451
7816999071
MDR Report Key3952303
MDR Text Key4626420
Report Number8030665-2014-00499
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,Consumer,User Facility
Reporter Occupation Attorney
Type of Report Initial
Report Date 05/20/2014
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/20/2014
Initial Date FDA Received06/19/2014
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 DIALYZER; NATURALYTE; 2008K HEMODIALYSIS SYSTEM; GRANUFLO; FMC SALINE
Patient Outcome(s) Death;
Patient Age64 YR
Patient Weight127
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