MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FMC HEMODIALYSIS BLOOD TUBING SET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)

Event Date 07/25/2014

Event Type  Injury  

Event Description

It was reported by the clinic that a pt had a cardiopulmonary arrest during hemodialysis treatment.The symptoms noted by the pt were trouble breathing.Observations by facility staff: change in the pt's level of consciousness, short of breath, hypotension.Contributing factors were noted by facility staff: downward trend or abnormal vial signs, multiple medications, recent hospitalization, congestive heart failure, peripheral vascular disease, seizure activity.Cardiopulmonary arrest intervention included chest compressions, oxygen administration, fluid replacement, ems team activated.The pt was transferred to local hospital by ambulance.

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.Based on the info provided, it is unknown how the device may have caused or contributed to the event.The post market clinical department is in the process of reviewing pt medical records and a plant investigation is underway.A supplemental report will be submitted upon completion of the clinical staff's assessment of the reported info and the plant's investigation.

• Brand Name: FMC HEMODIALYSIS BLOOD TUBING SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT; erika de reynosa, s.a. de c.v.; parque industrial reynosa; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4172548
• MDR Text Key: 5102686
• Report Number: 8030665-2014-00777
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• 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?: Yes
• Date Manufacturer Received: 09/11/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: SALINE; DIALYZER; NATURALYTE; FRESENIUS 2008K HEMODIALYSIS; GRANUFLO
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 49 YR