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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 3-2722-9
Device Problem Insufficient Information (3190)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802)
Event Date 06/06/2014
Event Type  Death  
Event Description
On (b)(6) 2014 the patient was seen in the emergency room (er) for lethargy and fever of 104.7.He was taken to the operating room for a cystoscopy and stent placement for an infected ureteric stone.Postoperatively, the patient was admitted to the icu, and was critically ill with positive fungal blood cultures, as well as acute kidney failure.The patient required intubation, and hemodialysis was initiated.The patient's status slowly improved and he was transferred to a medical unit on (b)(6) 2014.While receiving hemodialysis on (b)(6) 2014, the patient went into cardiopulmonary arrest.He received >35 minutes of advanced cardiac lift support.He was transferred back to icu.The patient's family made the decision to stop life sustaining measures.The patient died on (b)(6) 2014.
 
Manufacturer Narrative
This report is being submitted as part of a system level review; if any additional information is obtained a supplemental report will be submitted.Medical records information review: this event is being reported as a serious injury, although it is undetermined if there is a reasonable suspected causal relationship between the products and the event.There is no history of specific malfunction or product being out of specifications.The patient's multiple significant and severe co-morbidities may have resulted in his cardiopulmonary arrest and subsequent death after life support was removed.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 was performed and 13 lots were identified.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.A dhr review was performed on potential related lots.No nonconformances reports or other abnormalities during the assembly of these lots were found.The product involved met current specifications.There were no alleged product malfunctions or evidence that this device caused or contributed to the reported event.
 
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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 reyonosa
reynosa, tamaulipas 8878 0
MX   88780
Manufacturer Contact
corie vazquez, manager
920 winter street
waltham, MA 02451
7816999071
MDR Report Key3998063
MDR Text Key21175371
Report Number8030665-2014-00585
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 Other
Type of Report Initial
Report Date 07/01/2014
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 Number3-2722-9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/01/2014
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
2008K DIALYSIS SYSTEM; CITRASTATE; OPTIFLUX DIALYZER; NATURALYTE
Patient Outcome(s) Death;
Patient Age83 YR
Patient Weight75
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