FDA Adverse Event Death Summary report: N

NIPRO AVF TULIP NEEDLE

MDR report key: 14478275 · Received May 23, 2022

Report

Report Number
1056186-2022-00007
Event Type
Death
Date Received
May 23, 2022
Date of Event
April 29, 2022
Report Date
May 23, 2022
Manufacturer
NIPRO (THAILAND) CORP. LTD.
Product Code
MPB
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
MI, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

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 ELISIO-15H DIALYZER - 21J14F; NIPRO BLOOD TUBGIN SET - 20F15; CITRIC ACID - AC-200 - N1H007; NIPRO SDX HEMODIALYSIS MACHINE - 21EW0071.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1487741 NIPRO AVF TULIP NEEDLE AVF NEEDLE MPB NIPRO (THAILAND) CORP. LTD. FT+162530TP 21J06B

Patients

Seq Age Sex Outcome Treatment
1 68 YR Unknown Death