MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE COMBI SET

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.

• 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 Key: 3952303
• MDR Text Key: 4626420
• Report Number: 8030665-2014-00499
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• 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

• Date FDA Received: 06/19/2014
• 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
• Date Manufacturer Received: 05/20/2014
• 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 Number: 1
• Treatment: FMC DIALYZER; NATURALYTE; 2008K HEMODIALYSIS SYSTEM; GRANUFLO; FMC SALINE
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 127