MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2018-08-08 for LIPOSORBER LA-15 SYSTEM N/A manufactured by Kaneka Corporation.
[116791888]
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 (b)(6) 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
[116791889]
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 63/30, hr 105; 2nd blood pressure drop after first intervention: blood pressure drops to bp 110/?? , hr?? Angioedema (lips). Patient outcome: recovered after few minutes of medical intervention: bp 128/86 hr 84, bp 145/97, hr 70 after 25 min. Apheresis procedure completed (5000 ml treatment volume). After wards moved to plasma exchange 2 treatment procedures. Delivered with caesarean section. Remedial action taken by the healthcare facility relevant to the care of the patient 1 intervention: stop of plasma pump, volume substitution by infusion of 1000 ml saline solution, recovered - bp 125/78 hr 83. 2nd intervention after 2nd blood pressure drop: 1000 ml saline solution + corticosteroid, 145/97 hr 70 (after 25 min), regular termination of treatment after 5000 ml proceed plasma volume. 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 (b)(6) 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 (5000ml). Blood flow: 50 ml/min @ start / 100 ml @ 10 min. Plasma flow: 10% of blood flow (5 ml/min) @ start / 15% of blood flow (15 ml/min) @ 10 min / 25% of blood flow (25 ml/min) @ 15 min. Citrate: flow: 90 ml/min... 100 ml/h; tri-sodium citrate 8%. Calcium infusion: 1m cacl2 : 4 ml/ h.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808904-2018-00014 |
| MDR Report Key | 7763265 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2018-08-08 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-06-16 |
| Date Mfgr Received | 2018-07-11 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2018-08-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. YOSHIYUKI KITAMURA |
| Manufacturer Street | 2-3-18, NAKANOSHIMA, KITA-KU, |
| Manufacturer City | OSAKA CITY, OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 530-8288 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 SYSTEM |
| Generic Name | LIPOPROTEIN, LOW DENSITY, REMOVAL |
| Product Code | MMY |
| Date Received | 2018-08-08 |
| Model Number | LA-15 |
| Catalog Number | N/A |
| Lot Number | LAP1416 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORPORATION |
| Manufacturer Address | 2-3-18, NAKANOSHIMA, KITA-KU, OSAKA CITY, OSAKA 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-08 |