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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE

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FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE Back to Search Results
Model Number 2008K
Device Problem Fluid/Blood Leak (1250)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 08/28/2012
Event Type  Injury  
Event Description
The customer contacted tech support and stated that during a functional test following an adverse event, he noticed fluid leaking from the ultrafiltration (uf) check valve. The machine passed all tests prior to this use. The customer then stated that clinical staff noticed fluid leak while the pt was on the hemodialysis machine, in treatment. During this time, the pt coded. (b)(6) 2012: treatment initiated without incident; bp 114/78; hr 78. (1328): pt complained of not "feeling well;" the uf goal was reduced to 0. 3 kg and 200 ml normal saline (ns) given; bp 99/57; hr 78. (1331): pt became unconscious and pulseless with agonal breathing. The pt's blood was returned and 1000 ml ns given. Cardiopulmonary resuscitation (cpr) was initiated with the ambu bag for breathing support. The automated external defibrillator (aed) was applied with "no shock" advised. Twelve cycles of cpr were completed prior to emergency medical services (ems) arrival to the clinic. The pt was transported to hospital with pulse. Hospital admission: the pt was unresponsive and intubated with assist control at fi02 50%. The pt was unresponsive to verbal commands but responded to painful stimuli. The clinic manager reported, (b)(6) 2012: the pt subsequently expired due to multiple cardiac events related to pre-existing cardiac problems for which the hemodialysis machine did not cause or contribute.
 
Manufacturer Narrative
Medical records were provided for review. The pt has a history of severe cardiomyopathy, with ejection fraction of 15%, diabetes mellitus, obesity, end stage renal disease; he had an icd in place, as well as a right ij hemodialysis catheter. His first treatment on dialysis was (b)(6) 2012, when he stated to the dietician that he also needed a heart transplant. It is also important to note that this pt presented to the hospital with leukocytes and bandemia, possibly adding another cardiac stressor. On (b)(6) 2012, pt became unconscious approx 2 hours into his 3rd dialysis treatment; it was later determined upon hospitalization that he had suffered a cardiopulmonary arrest, was admitted to the intensive care unit, and eventually expired on (b)(6) 2012. The dialysis device involved during this event had been previously used for another hemodialysis treatment on the same day prior to the event of the pt experiencing a code. The reported uf check valve leak found during user facility device investigation is not likely to result in serious injury. According to the fresenius r & d engineers, the uf check valve is outside the fluid balancing system and this type of malfunction may result in fluid leaks but does not affect uf. The fresenius regional equipment specialist (res) conducted a hemodialysis machine investigation on (b)(6) 2012, following the replacement of the uf check by the facility biomed tech and determined that the machine functioned within manufacturer's specifications.
 
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Brand NameFRESENIUS DIALYSIS DELIVERY SYSTEM
Type of DeviceHEMODIALYSIS MACHINE
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
walnut creek CA
Manufacturer Contact
jerry succoro, ccht, ma
2637 shadelands dr.
walnut creek, CA 94598
9252950200
MDR Report Key3010267
MDR Text Key17952956
Report Number2937457-2013-00021
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/28/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2008K
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/26/2012
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/28/2012
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/12/2013 Patient Sequence Number: 1
Treatment
ACID CONCENTRATE, 3251; F160 NRE DIALYZER, BLOODLINE, SALINE,; BICARBONATE
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