MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-20 for SPECTRA OPTIA 10220 manufactured by Terumo Bct.
[188576696]
Lot number and expiry information are not available at this time. Investigation: per the article, "although a significant number of patients experienced mild to moderate complications related mostly to hypocalcemia and allergic reactions, tpe-related mortality or severe complications are infrequent, and tpe is a relatively safe therapy. " this was a retrospective study in a multi-institutional cohort of 109 patients with ittp between 2004 and 2017. This study included patients presenting between january 8, 2004, and april 26, 2017, with confirmed ittp at four large academic medical centers in boston. Venous access was often obtained via temporary dual-lumen apheresis catheters placed in the internal jugular or, less commonly, the femoral vein. Procedures were performed using an apheresis machine (cobe spectra or optia, terumo bct). Both standard (not virus inactivated) fresh frozen plasma and cryoprecipitate-poor plasma were used as replacement fluid, as designated by the treating physician. Anticoagulant citrate dextrose a solution was routinely infused at 1:10 inlet ratio for anticoagulation. Calcium gluconate was infused continuously throughout each procedure, and the infusion rate was increased in the setting of symptomatic hypocalcemia. Ionized calcium was not routinely measured when symptoms of hypocalcemia were reported. Most patients underwent daily, one plasma-volume exchanges. They identified 124 patients who presented with acute ittp between january 8, 2004, and april 26, 2017, at one of the six participating institutions. The majority of patients were treated at hospitals within the harvard tma research collaborative (table 1). Overall, 104 patients were enrolled during their first episode of acute ittp, while 20 were enrolled during a relapsed presentation. The median (interquartile range [iqr]) age of our patient cohort was 42 years (31-52), 69% were female, and 42% were non-caucasian. The median (iqr) platelet count at presentation was 16,000 (10,000-22,000) per microliter, and the median (iqr) adamts13 activity level was 0% (0%-0%). The vast majority of patients were treated during the index event (defined as the event that led to their enrollment in our study). Complications of tpe were analyzed in a subset of this cohort (74 patients representing 101 treatment courses consisting of a total of 1497 procedures. ) complications were categorized as allergic, moderate hypocalcemia, catheter-related (infectious and noninfectious), non? Catheter-associated infectious, and nonallergic transfusion reactions. Allergic reactions were considered mild if limited to urticaria and treated with a single dose of antihistamine. Allergic reactions with symptoms beyond isolated urticaria or requiring additional treatment with type 2 histamine receptor blockers or steroids were considered moderate, and any reaction requiring epinephrine was considered severe (anaphylaxis). Hypocalcemic reactions were considered moderate if patients had symptoms in addition to tingling, including muscle cramps, nausea, vomiting, hypotension, or chest pain. Seventeen patients were treated with two or more courses of tpe. Fifty-six of 74 patients (76%) experienced at least one complication from tpe. Most frequent were mild urticarial reactions requiring a single dose of diphenhydramine, which occurred in 34 of 101 courses of tpe (34%). More significant allergic reactions requiring steroids and/or type 2 histamine receptor blockers occurred during 15 of 101 courses (15%), and 4 of 101 courses (4%) resulted in anaphylaxis requiring treatment with epinephrine. Other complications included moderate hypocalcemia in 9 of 101 courses (9%) and catheter related complications in 12 of 101 courses (12%), including two line-associated infections, one thrombotic complication requiring systemic anticoagulation, two bleeding complications, six catheter failures related to line thrombosis or placement error, and one line-induced supraventricular tachycardia. Overall, 7 of 101 (6. 9%) treatment courses had at least one severe adverse event, defined as the sum of anaphylaxis, line associated infections, and thrombosis requiring systemic anticoagulation. There were no suspected or confirmed cases of transfusion-related acute lung injury. . The authors had hypothesized that refractory disease, as defined by a high number of tpe treatments or long duration of hospitalization, might be associated with mortality. However, they found that neither extremes in length of hospital stay nor number of tpe procedures was predictive of mortality. The majority of deaths (5/8) were associated with delay in the diagnosis of ittp or initiation of tpe or presentation to the hospital in a moribund state. See attached article for full study details. Article citation: colling, m. , et. Al. 2020. Deaths and complications associated with the management of acute immune thrombotic thrombocytopenic purpura. Transfusion 2020;9999;1? 6. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[188576697]
Per the article 'deaths and complications associated with the management of acute immune thrombotic thrombocytopenic purpura' in the journal transfusion, a retrospective study was performed on 109 immune thrombotic thrombocytopenic purpura (ittp) patients between 2004 and 2017. Complications of therapeutic plasma exchange (tpe) were analyzed in a subset of the cohort. Complications were categorized as allergic, moderate hypocalcemia, catheter-related (infectious and noninfectious), non? Catheter-associated infectious, and nonallergic transfusion reactions. Allergic reactions were considered mild if limited to urticaria and treated with a single dose of antihistamine. Allergic reactions with symptoms beyond isolated urticaria or requiring additional treatment with type 2 histamine receptor blockers or steroids were considered moderate, and any reaction requiring epinephrine was considered severe (anaphylaxis). Hypocalcemic reactions were considered moderate if patients had symptoms in addition to tingling, including muscle cramps, nausea, vomiting, hypotension, or chest pain. There were 68 occurrences of these complications. Exact details of the complications, including patient information, exact medical intervention provided, and patient outcomes, were not provided. A summary of the complications was included in the article. This report is for the 67 reactions based on the summary provided. Number of events: - 53 allergic reactions [34 mild: hives requiring diphenhydramine alone, 15 moderate: symptoms requiring steroids/antihistamines, 4 severe: anaphylaxis requiring epinephrine] - 9 moderate hypocalcemia - 4 line-associated complications [1 thrombotic line complications*, 2 catheter insertion site bleeding**, 1 catheter-induced supraventricular tachycardia] *clotting required systemic anticoagulation as mitigation **catheter insertion site bleeding resolved with local measures and did not require rbc transfusion - 2 non-allergic transfusion reaction detailed patient information and information is not available for these events. The disposable sets are not available for return because they were discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00122 |
| MDR Report Key | 9860156 |
| Report Source | LITERATURE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-26 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| 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 |
| Product Code | LKN |
| Date Received | 2020-03-20 |
| 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; 2. Required No Informationntervention | 2020-03-20 |