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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO CORPORATION (ODT) NIPRO ELISIO-H DIALYZER

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NIPRO CORPORATION (ODT) NIPRO ELISIO-H DIALYZER Back to Search Results
Model Number DD+ELISIO-15H
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of consciousness (2418); Low Oxygen Saturation (2477); Decreased Respiratory Rate (2485)
Event Date 04/29/2022
Event Type  Death  
Event Description
At 10: 54 am, with 34 minutes into a 2. 5 hrs treatment, patient said he needs to use the restroom due to bowel movement and was restless, bp was 84/42 mmhg, p
=
67. Staff put patient on t position and staff noticed after that patient had a blank stare and was unresponsive. Nurse was called, blood was returned, and treatment was ended. Nurse did a chest rub, gave oxygen and 911 was called. At 11:03 am blood sugar was 113mg/dl. 11:06 am - bp was 127/66, p 119, but respiratory rate was only 2 and nurse was giving oxygen through ambu bag. Paramedics came and pronounced the patient deceased at 11:17 am. Family was contacted and decided not to send patient to the hospital. Patient had previously signed a dnr on (b)(6) 2022. Patient has a history of non-compliance, missing and not completing treatments. Patient treatment orders/information: tx time - 2. 5 hrs; bfr - 300; dfr - 500; edw - (b)(6). Patient came in @ (b)(6), goal set at 600 ml. Bp at start of treatment - 90/51 mmhg, p
=
66. Only heparin 2000 units was given. No new medications started. Other products used during the event: nipro sdx blood tubing set - 20f15; nipro avf tulip 16g needle - 21j06b; citric acid - ac-200 - n1h007; nipro sdx hemodialysis machine - 21ew0071.
 
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Brand NameNIPRO ELISIO-H DIALYZER
Type of DeviceDIALYZER
Manufacturer (Section D)
NIPRO CORPORATION (ODT)
8-7, hanuki-yachi, niida-aza
ohdate-shi, akita 018-5 794
JA 018-5794
Manufacturer (Section G)
NIPRO CORPORATION (ODT)
8-7, hanuki-yachi, niida-aza
ohdate-shi, akita 018-5 794
JA 018-5794
Manufacturer Contact
michelle tejada
3150 nw 107th avenue
miami, FL 33172
3055997174
MDR Report Key14477874
MDR Text Key292468983
Report Number9610987-2022-00004
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDD+ELISIO-15H
Device Catalogue NumberDD+ELISIO-17H
Device Lot Number21J14F
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/23/2022 Patient Sequence Number: 1
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