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Model Number DD+CT15H
Device Problem Device Alarm System (1012)
Patient Problems Death (1802); Edema (1820); High Blood Pressure/ Hypertension (1908); Hypoventilation (1916); Decreased Respiratory Rate (2485)
Event Date 06/14/2019
Event Type  Death  
Event Description
Patient was in the hospital and started as an acute kidney injury patient. Approximately 4. 5hrs into acute hemodialysis treatment (treatment initiated at 14:42) at the hospital, machine alarmed for blood leak, immediately prior to the alarm he was started on a nitroglycerin drip as well as nicardipine and seems to have been on the hemopure, fentanyl and midazolam all day, patient developed a severe spike in blood pressure prior to the alarm (patient removed from treatment at 19:35). Dialyzer was not tested for blood leak to confirm positive blood leak. During treatment: patient was noted to be hypertensive in with systolic in the 180-190s around 6:45pm. This happened acutely, his bp was around 120/60 for most of the day. His bp rapidly went up to 260s sbp within 15 minutes. Likely secondary to hemopure (the drug is known to have vasoactive effects and also cause volume overload) and epo (40,000 units) that he got earlier today. Started nitro drip to titrate for sbp 130-160 mmhg within 15 min of noting hypertension. Around 7:10 pm patient's ventilator started to alarm and his minute ventilation was noted to have dipped acutely from 14-18 to 7. He also was noted to have stopped making spontaneous respiratory efforts over the set rate. His pupils were examined and found to be fixed and dilated and not responsive to light. Pupils had been reactive around 5 pm when last checked by his nurse. Doctor was called to see if we could potentially remove some fluid with dialysis as hemopure is known to cause volume overload. However, soon as uf was attempted, dialysis machine started detecting a blood leak. Per doctor, the hemopure molecule may have been filtered through to the dialysate and may have triggered the warning. Further dialysis was therefore aborted and all the "blood" in dialysis circuit was returned to patient. Patient suffered massive cerebral edema and was made comfort care, patient deceased. Per the doctor, blood leak was not likely to cause injury to the patient, there is no evidence to support this. The cerebral edema occurred certainly prior to the leak and was attributed to severe anemia, they are not certain if it was a real leak or an effect of one or more medications administered. Priming procedure: standard priming, 0. 9% saline used. Medications: patient was on experimental drug named hemopure. Physician was not certain if blood leak alarm was a false positive due to this medication. Patient also received epogen via infusion. Only medication administered through the dialysis circuit was heparin 1000u/hr. Medications administered during treatment through other means: tylenol 650mg, epogen sq 40,000u, hemopure 30gm in 250ml lr, hydralazine 20mg iv, methylene blue 96mg iv, vitamin c 1000mg iv, zithromax 500mg iv, venofer 200mg iv, lacosamide 100mg iv, fentanyl 150mcg/hr iv, versed 14mg/hr iv.
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Type of DeviceDIALYZER
Manufacturer (Section D)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
MDR Report Key8809373
MDR Text Key151697741
Report Number1056186-2019-00009
Device Sequence Number1
Product Code KDI
UDI-Device Identifier40383790004389
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model NumberDD+CT15H
Device Lot Number19D04C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/19/2019
Distributor Facility Aware Date06/21/2019
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer07/19/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/19/2019 Patient Sequence Number: 1