MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO CELLENTIA DIALYZER

Model Number DD+CT15H

Device Problem Leak/Splash (1354)

Patient Problem Death (1802)

Event Date 06/14/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).

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.

• Brand Name: NIPRO CELLENTIA DIALYZER
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• Manufacturer (Section G): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 8809333
• MDR Text Key: 151701736
• Report Number: 9610987-2019-00007
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 40383790004389
• UDI-Public: 40383790004389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• 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 Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: DD+CT15H
• Device Lot Number: 19D04C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death