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 2020-03-20 for SPECTRA OPTIA 10220 manufactured by Terumo Bct.
[184333644]
Lot number and expiry information are not available at this time. Investigation: 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). 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 in the study. 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
[184333645]
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. Four deaths occurred in the study for patients who had undergone tpe procedures. This report is for one of the four patients who expired. All deaths recorded in the cohort were considered. An ittp related death was defined as any death occurring within 90 days of the onset of active disease regardless of clinical recovery and hospital discharge. This patient died after 27 sessions of tpe after experiencing neurologic deterioration and 25 days after presentation of disease state. Patient weight is unavailable at this time. The disposable set is not available for return because it was discarded by the customer. This report is being filed due to patient death, though at this time there is no indication that the device caused or contributed to the death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00119 |
| MDR Report Key | 9860142 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| 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 | 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 |
| 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 | 2020-03-20 |