LIPOSORBER LA-15 SYSTEM N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-08-08 for LIPOSORBER LA-15 SYSTEM N/A manufactured by Kaneka Corporation.

Event Text Entries

[116448648] The manufacturer has received in total 3 incident reports from the same hospital; the reported events have occurred during treatment of pregnant women with pre-eclampsia. Patient are treated in an investigator initiated clinical trial. Medical device liposorber la-15 was used outside the intended purpose (removing of lipoprotein such as vldl, ldl and lp(a) from patients with dyslipidemia) for treatment of pre-eclampsia patients under an iit study carried out by the physician of the center. Treatment protocol and all set-up details like use of sodium citrate anticoagulation were not in context with instruction for use. Liposorber la-15 is intended for use with heparin anticoagulation since date for regional citrate anticoagulation (rca) are not available yet. Citrate delivery could not be controlled by the used apheresis equipment ma-03. Even company experience from pre-eclampsia studies from the past (raapid i, raapid ii) using of liposorber devices (liposorber la- 15, liposorber d) were not considered, as kaneka was not informed about planned / ongoing iit study and wasn't involved in the design, review, and approval of this approach. The attending physician commented that the relationship between the ldl-apheresis and the reported event is "possibly related". Since we could not completely decline the relevance between the ldl-apheresis and the incident, we decided to make a mdr as a case caused sae. We believe this incident is attributable not to defect or malfunction of the devices but the treatment conditions out of ifu and the indication which is not approved.
Patient Sequence No: 1, Text Type: N, H10


[116448649] Patient pregnant, pre-eclampsia; apheresis treatment (liposorber la -15), event occurred at 1st apheresis treatment session after 30 min treatment: blood pressure drops to bp 66/33, hr 48, 2nd blood pressure drop after first medical intervention, blood pressure drops to bp 80/40, hr 42, angioedema (lips). Patient outcome: recovered after 30 min bp 137/73 hr 72, (intervention and premature apheresis termination), afterwards moved back to plasma exchange 2 treatment procedures, delivered with caesarean section. Remedial action taken by the healthcare facility relevant to the care of the patient: 1st intervention: volume substitution by infusion of 1000 ml ringer (lactate solution) + efedrin (ephedrine), bp increased to bp 95/48 hr 68, plasma flow reduced to 8 ml/min (105 of 80 ml/min blood flow). 2nd intervention: 0,5 mg atropine + additional volume substitution by infusion of 1000 ml saline solution (in total 2000 ml infusion), premature termination of treatment after 686 ml proceeded plasma volume. Thirty (30) min after premature termination, bp 137/73 hr 72. Initial e-mail of the attending physician (received 2018-07-12): "we are performing a study with ldl apheresis for severe preeclampsia. We have included 4 women. In 3 of them we had relatively severe reactions with severe hypotension and also quinque edema of lips, which we believe were mediated by bradikinin and started soon after starting apheresis and required termination of the procedure and switch to plasma exchange. The procedure was started slowly, with gradually increasing plasma flow. All women were taking only methyldopa or even nothing. The circuits were primed with bicarbonate. " technical information: treatment goal: (processing of 2 plasma volume ), blood flow: 100 ml/min @ start , plasma flow: 10% of blood flow (10 ml/min) @ start; 15% of blood flow (15 ml/min) @ 10 min; 20% of blood flow (20 ml/min)@ 20 min, citrate: flow: 100 ml/h, calcium infusion: 1 m cacl2 : 4 ml/ h (1 m).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002808904-2018-00015
MDR Report Key7763275
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2018-08-08
Date of Report2018-07-11
Date of Event2018-06-30
Date Mfgr Received2018-07-11
Device Manufacturer Date2016-04-01
Date Added to Maude2018-08-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. YOSHIYUKI KITAMURA
Manufacturer Street2-3-18, NAKANOSHIMA, KITA-KU,
Manufacturer CityOSAKA CITY, OSAKA 530-8288
Manufacturer CountryJA
Manufacturer Postal530-8288
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIPOSORBER LA-15 SYSTEM
Generic NameLIPOPROTEIN, LOW DENSITY, REMOVAL
Product CodeMMY
Date Received2018-08-08
Model NumberLA-15
Catalog NumberN/A
Lot NumberLAP1416
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKANEKA CORPORATION
Manufacturer Address2-3-18, NAKANOSHIMA, KITA-KU, OSAKA CITY, OSAKA 530-8288 JA 530-8288


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.