MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-27 for SPECTRA OPTIA 10220 manufactured by Terumo Bct.
[185257096]
Lot number and expiry information are not available at this time. Investigation: per the article, "of the procedures, 62% were performed using peripheral venous access, even in patients with a low inlet blood flow. A central catheter was required only in 15% cases, and an arteriovenous fistula in 23% of the procedures. Anticoagulation management differed in both procedures. The la procedures required a higher amount of citrate as they were performed using only citrate. The ia procedures required less citrate because a mixture of citrate and heparin was used. They did not observe clotting or bleeding, regardless of heparin use. The anticoagulation in la was realized with acd-a alone, with a ratio of 12:1 (11 parts whole blood [wb] to 1 part acd-a) as recommended by the manufacturer. In ia, they continuously infused heparin (10,000 u in 50 ml saline, 5 ml/h), in addition to acd-a with a ratio of 15:1. A bolus of heparin prior to ia was not administered. Due to strict calcium management, no patient showed signs of hypocalcemia. All patients received 10% calcium gluconate as an infusion during spd treatment. Despite their apheresis management, four procedures had to be canceled preliminarily due to patient complications. " per the article "the cobe could be replaced by the optia system effectively. The optia has a high plasma extraction efficiency, which allows spd procedures with peripheral venous access and moderate inlet flow rates. " article citation: rummler, silke, et. At. (2017). Spectra optia apheresis system: experience with secondary plasma devices. International journal of clinical transfusion medicine. 2017:5 61? 67. Investigation is in process. A follow up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[185257097]
Per the article, 'spectra optia apheresis system: experience with secondary plasma devices' in the international journal of clinical transfusion medicine, a study was done on "300 data logs from patients treated with spectra optia from november 2015 until october 2016. Of these 300 procedures, 149 secondary plasma treatments were conducted in 13 patients (76 immunoadsorption [ia] and 73 lipoprotein apheresis [la]). Nine patients had ia due to transplantation and autoimmune diseases. Four patients were treated with la after heart transplantation. " per the article, "seventy-three la procedures were performed in four patients with severe drug-refractory transplant vasculopathy (stanford iiia? Iv) several years after cardiac transplantation. All patients had an elevated level of lpa or ldlcholesterol and a history of vascular events. At least 3 years earlier, before la treatment was initiated, three of the four patients with dyslipoproteinemia had high initial isolated lpa, ranging from 596 to 1802 mg/l with a mean of 1072 mg/l (n < 300 mg/l). Several treatments later, the lpa successively dropped down to 668 (262? 1236) mg/l. Looking at the trend line, a decrease of lpa can be seen over the years. With one session of la, the lpa level could be reduced significantly by 68% (76%? 45%). When treating the patients with la, no cardiac events, rejection episodes, or stenting requirements were observed. One of these four patients presented an increased ldlcholesterol? An average of 6. 79 (5. 13? 8. 14) mmol/l (n < 2. 59 mmol/l)? And a high ldl/hdl ratio of 2. 5 (1. 8? 3. 5). The ldl-cholesterol could be reduced by 57% (64%? 37%) as well as the ldl/hdl ratio to 1. 15 (0. 7? 1. 9). Unfortunately, this patient was nonadherent, and hence, could not be treated regularly, and died after a severe cardiac infarction. " patient information is not available at this time. This report is being filed due to patient death, though at this time, there is no allegation that the device caused or contributed to the patient death. The disposable set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00142 |
| MDR Report Key | 9889018 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2015-11-01 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SCOT HILDEN |
| Manufacturer Street | 10810 W.COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032314970 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRA OPTIA |
| Generic Name | SPECTRA OPTIA EXCHANGE SET, EA |
| Product Code | LKN |
| Date Received | 2020-03-27 |
| Catalog Number | 10220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT |
| Manufacturer Address | LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-27 |