MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008T HEMODIALYSIS MACHINE WITH CDX

Device Problems Use of Incorrect Control/Treatment Settings (1126); Delivery System Failure (2905)

Patient Problems Nausea (1970); Dizziness (2194); Confusion/ Disorientation (2553)

Event Date 07/02/2013

Event Type  Injury  

Event Description

A voluntary medwatch form was received by the manufacturer from the chronic hemodialysis facility.The following was reported.At 2 hr 30 min into hemodialysis treatment, pt complained of nausea and dizziness.Pt was pale.She was placed in trendelenburg position and normal saline given.Bp within normal limits.Pt placed on oxygen.Five minutes later the pt complained of cramping in her foot.Goal was decreased.At the end of treatment the pt's level of consciousness was altered and she was sent to the emergency room (er) and admitted to the hosp.The pt became unresponsive in the emergency room.She appeared to be seizing and became pulseless with agonal respirations and required add'l invasive treatment.Admission diagnosis was syncope and collapse.Hosp course-admitted with respiratory failure and altered level of consciousness with questionable seizure activity in the emergency dept.These issues were felt to be secondary to renal lab abnormalities.She was intubated and remained so for 48 hrs.Developed a pneumonia which was resolving.She was discharged from the hosp on (b)(6) 2013 with the discharge diagnosis of esrd; respiratory failure-status post intubation and continues on hemodialysis.

Manufacturer Narrative

The dialysis machine was removed from service after the event and labs drawn from the machine.It was further revealed the bicarb pump had failed and the conductivity alarms had been changed resulting in the machine not alarming when conductivity may have been below normal limits.Manufacturer field tech evaluated the device and the complaint was confirmed.The device was repaired and it subsequently passed all functional checks and self tests.Medical records have been reviewed.Clinical assessment: the serious injury is most likely due to the machine malfunction.Plant investigation is pending.A supplemental medwatch will be submitted upon completion.

• Brand Name: 2008T HEMODIALYSIS MACHINE WITH CDX
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3848039
• MDR Text Key: 4406092
• Report Number: 2937457-2014-00817
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• 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
• Date Manufacturer Received: 07/17/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2012
• 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: METOPROLOL; NIFEDIPINE; FRESENIUS GRANUFLO; FRESENIUS SALINE; FRESENIUS BLOODLINE; FRESENIUS BICARB
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 60