MAUDE MDR 6183189

MDR report key
6183189
Report number
9614654-2016-00009
Event key
0
Event type
3
Date of event
2016-03-17
Date received
2016-12-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR KAZUHIKO INOUE
Address
2-3-18,NAKANOSHIMA,KITA-KU OSAKA-CITY 530-8 JA
Phone
461-461-4613
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIPOSORBER LA-15 SYSTEMLIPOPROTEIN, LOW DENSITY, REMOVALKANEKA CORP.MMYR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-12-1601. L

Event Narratives#

N

Patient 1

THE LDL-A WAS STARTED IMMEDIATELY AFTER COMPLETING THE HD. THE EXTRACORPOREAL VOLUME OF THE LDL-A SYSTEM IS LARGER THAN THAT OF THE HD SYSTEM, AND THE PATIENT MIGHT HAVE DEVELOPED A HYPOVOLEMIA ESPECIALLY IMMEDIATELY AFTER THE HD DURING WHICH THE PATIENT HAD ALREADY LOST A CERTAIN AMOUNT OF CIRCULATING BLOOD VOLUME. FURTHERMORE, THE PATIENT WAS TAKING AN ANTI-HYPERTENSIVE DRUG AND IT MIGHT ACCELERATE TO CAUSE HYPOTENSION DURING THE LDL-A. WE BELIEVE THE REPORTED EVENT WAS DUE TO THE PATIENT'S INTOLERANCE TO THE COMBINATION PROCEDURE WITH THE HD AND THE LDL-A, AND NOT DUE TO ANY DEFECT OR MALFUNCTION OF THE LDL-A SYSTEM. IF POSSIBLE, COMBINATION TREATMENT OF HD AND LDL-A ON THE SAME DAY SHOULD BE AVOIDED, AND IF IT CANNOT BE AVOIDED, THE LDL-A FIRST AND FOLLOWED BY HD MAY HAVE LESS RISK TO DEVELOP A HYPOVOLEMIC SHOCK SYMPTOM. FURTHERMORE, IF POSSIBLE, TAKING ANY ANTIHYPERTENSIVE DRUG BEFORE THE LDL-A HAS COMPLETED SHOULD BE SKIPPED ON THE DAY OF THE LDL-A.

D

Patient 1

THE LDL-APHERESIS USING THE LIPOSORBER LA-15 SYSTEM (LDL-A) WAS INTRODUCED TO A (B)(6) MALE PATIENT ON MAINTENANCE HEMODIALYSIS (HD) FOR THE TREATMENT OF HIS ARTERIOSCLEROSIS OBLITERANS (ASO). ASO IS NOT INCLUDED IN THE INDICATIONS OF THE LDL-A APPROVED BY FDA IN THE USA. THE HD WAS FIRST CONDUCTED AND FOLLOWED BY THE LDL-A ON THE SAME DAY. BEFORE STARTING THE LDLA, HIS BLOOD PRESSURE (BP) WAS OVER 100MMHG AND WAS STABLE. THE LDL-A WAS STARTED AT A BLOOD FLOW RATE (QB) OF 140ML/MIN AND A PLASMA WITHDRAWAL RATIO (QF/QB) OF 25%, BY USING HEPARIN AS AN ANTICOAGULANT. AT AROUND 30MIN AFTER STARTING THE LDL-A, THE PATIENT ALLEGED TIREDNESS AND THE BP ABRUPTLY DROPPED DOWN TO 53MMHG AND FELL INTO A SHOCK. THE PATIENT WAS SUPPLEMENTED WITH 100ML OF SALINE AND THE LDL-A WAS CONTINUED AT A QB OF 100ML/MIN WITH A QF/QB OF 25%. IN 15 MIN, THE BP RETURNED TO 130 MMHG, HOWEVER THE LDL-A WAS DISCONTINUED DUE TO THE PATIENT'S REQUEST.