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MAUDE MDR 7955393

MDR report key
7955393
Report number
7955393
Event key
0
Event type
3
Date of event
2018-08-08
Date received
2018-10-03
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
501
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WINGEATER JMS 15 GAUGE X 1 INCH BE WITH CLAMP FUSTULA NAV FISTULA NEEDLEJMS SINGAPORE PTE LTDFIE820-5002-33180116351I N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-031601. D; 2. H; 3. L

Event Narratives#

D

Patient 1

AT 12:35, APPROX 1 HOUR 30 MINS INTO SCHEDULED 3.5 HOUR HEMODIALYSIS TREATMENT, PT'S B/P WAS 90 SYSTOLIC AND PT WAS DIFFICULT TO AROUSE. VS AT 12:06: B/P: 118/62; PULSE 87. BLOOD WAS NOTED UNDER PT'S CHAIR. THE BLOOD PUMP WAS STOPPED AND ACCESS WAS ASSESSED. ARM WAS NOTED TO HAVE DROPPED INTO CHAIR, CAUSING TENSION ON VENOUS LINE. THE VENOUS FISTULA NEEDLE WAS NOTED TO BE DISLODGED. PRESSURE WAS HELD TO VENOUS SITE; BLOOD WAS RETURNED AND NORMAL SALINE WAS ADMINISTERED VIA THE ARTERIAL FISTULA NEEDLE. OXYGEN WAS APPLIED VIA NASAL CANNULA; 911 WAS CALLED. PT DID NOT AROUSE WITH PAINFUL STIMULI; PT APPEARED TO HAVE AGONAL BREATHS WITH NO PULSE. CPR WAS INITIATED WITH ONE ROUND ADMINISTERED BEFORE PT OPENED EYES AND MUMBLED TO STAFF. PALPABLE PULSE AND APICAL HEART SOUNDS AUSCULTATED. APPROX 800 ML NORMAL SALINE ADMINISTERED. HEMOSTASIS ACHIEVED ON VENOUS CANNULATION SITE. PT TRANSPORTED TO ER VIA EMS. ADMITTED TO HOSP AND TRANSFUSED WITH 2 UNITS PACKED RED BLOOD CELLS. UPON INSPECTION OF THE VENOUS AVF NEEDLE, IT WAS NOTED THAT THE TAPE AND GAUZE DRESSING WERE STILL INTACT ON THE FISTULA NEEDLE.

D

Patient 1

THIS IS A F/U REPORT TO A PREVIOUSLY SUBMITTED MEDWATCH. INFO WAS OBTAINED AS FOLLOWS: PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018 AND SUSTAINED A CARDIOPULMONARY ARREST IN HER HOME ON (B)(6) 2018, RESULTING IN HER DEATH.