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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.
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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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