MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008T HEMODIALYSIS SYS., WITH CDX

Device Problems Loose or Intermittent Connection (1371); Split (2537); Device Operates Differently Than Expected (2913)

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 12/23/2013

Event Type  Injury  

Event Description

A hemodialysis nurse reported that a patient had three episodes of hypotension and one episode of loss of consciousness during dialysis treatment.The patient was treated with normal saline and 2l/min of oxygen via nasal cannula during a 20 minute time period.Emergency medical services (ems) were activated and the patient was taken to the emergency room for evaluation, but was not admitted.Vital signs were reported as blood pressure 57/49mmhg and heart rate 69 beats per minute and 500ml of normal saline (ns) was administered.The patient's blood pressure was then 100/70mmhg with a heart rate of 70 beats per minutes and 700ml ns was administered.Her blood pressure was 90/62mmhg and her heart rate was 70 beats per minuted and an additional 400mls of ns were administered.The biomedical technical team assessed that the machine was spraying fluid and the rear hose bib and tubing was split.

Manufacturer Narrative

A review was performed by the post market physician of the medical records provided: a patient receiving hemodialysis suffered several episodes of hypotension during treatment.His dry weight was reported as 67.5kg, his weight before treatment was 69.7kg and a goal weight reduction of 1.6kg was aimed to be removed.After the hypotension events, the machine was found to be "spraying fluid against the wall behind the machine and rear hose bib and tubing was split per the biomedical technical team who were notified of the adverse event".This event will be reported as serious injury with a malfunction.A supplemental report will be submitted upon completion of plant's investigation.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA, WALNUT CREEK PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3640909
• MDR Text Key: 16449895
• Report Number: 2937457-2014-00147
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MEDISYSTEM STREAMLINE BLOODLINES; FRESENIUS OPTIFLUX DIALYZER; SALINE; MEDISYSTEM FISTULA NEEDLE; ROCKWELL ACIDS; FRESENIUS BLOODLINES
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 68