MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE COMBI SET

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908)

Event Date 12/14/2009

Event Type  Injury  

Event Description

The following is based on medical records provided by the plaintiff's attorney.Upon review of medical records for a legal complaint, it was discovered that the pt had a headache that reportedly started during dialysis treatment earlier in the day.The pt went to the emergency room and was admitted with severe headache, and uncontrolled, hypertension.She was started on cardene drip and transferred to icu for continuation of therapy.

Manufacturer Narrative

This report is being submitted as part of a system level review; which will include an investigation of all potential fresenius products being used at the time of the event.A supplemental report will be submitted upon completion of the plant's investigation.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 specs.The allegation of serious injury remain speculative in nature.The event reported on this pt involves five separate products and associated with mdrs # 2937457-2014-01144, 1225714-2014-05000, and 05001.

• 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; reynosa 8878 0; MX 88780
• Manufacturer Contact: corie vazquez ; 920 winter st.; waltham, MA 02451 ; 7816999071
• MDR Report Key: 3949605
• MDR Text Key: 4646123
• Report Number: 8030665-2014-00498
• 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: 2008K DIALYSIS SYSTEM; GRANUFLO; NATURALYTE; FMC SALINE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 79