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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE CUSTOM COMBI SET

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FRESENIUS MEDICAL CARE CUSTOM COMBI SET Back to Search Results
Catalog Number 03-2742-9
Device Problem Insufficient Information (3190)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 06/26/2014
Event Type  Injury  
Event Description
It was reported by the clinic that the pt started her hemodialysis without difficulty, her vital signs were stable.A short time later, the pt stated that she was having difficulty breathing.The pt was started on oxygen via nasal cannula and then became pulseless.Cardiopulmonary resuscitation was initiated, the automated external defibrillator was applied, one cycle of cpr was performed and the pt regained consciousness.The pt was sent to the emergency room for further eval.
 
Manufacturer Narrative
This report is being submitted as part of a system level review.If any add'l info is obtained a supplemental report will be submitted.Clinical info reviewed: medica records info review indicates that on (b)(6) 2014, 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 product being out of specification.The device investigation has not been completed.There were no products returned for investigation.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 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.Dhr 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.Complaint sample was not provided for eval and there is no device malfunction reported.The event reported on this pt involves six separate products.
 
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Brand Name
CUSTOM 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
920 winter st
waltham, MA 02451
7816999071
MDR Report Key4012967
MDR Text Key19762514
Report Number8030665-2014-00580
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 06/30/2014
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 Catalogue Number03-2742-9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/30/2014
Initial Date FDA Received07/30/2014
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
2008K2 DIALYSIS SYSTEM; NATURALYTE; FMC SALINE; GRANUFLO; FMC DIALYZER
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age64 YR
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