MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE BONDED COMBISETS

Model Number 03-2742-9

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 06/17/2014

Event Type  Injury  

Event Description

It was reported by the dialysis clinic that on (b)(6) 2014 during hemodialysis treatment the pt became short of breath approx four minutes into treatment.Oxygen applied via nasal cannula.By 6 minutes into treatment, pt became unresponsive and arrested.The pt was resuscitated and transported to a local hospital and admitted to the critical care unit.Additional info has been requested.

Manufacturer Narrative

This report is being submitted as part of a system level review; if any additional info is obtained, a supplemental report will be submitted.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 tot he 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 the identified lots.No nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met current specs.No conclusion can be drawn regarding the complaint without an examination of the product used during the reported event.The event reported on this pt involves six separate products.Medical records review: 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 products being out of spec.

• Brand Name: BONDED COMBISETS
• 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 8 8780; MX CP 88780
• Manufacturer Contact: corrie vazquez, mgr ; 920 winter st; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4043996
• MDR Text Key: 4802750
• Report Number: 8030665-2014-00565
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/23/2014

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 Model Number: 03-2742-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 07/23/2014
• 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 0/9% SALINE; GRANUFLO; FMC DIALYZER; NATURALYTE; 2008 DIALYSIS SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 55