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 2020-03-24 for SPECTRA OPTIA 10220 manufactured by Terumo Bct.
[184720792]
Lot number and expiry information are not available at this time investigation: the majority of procedures performed were therapeutic plasma exchange (tpe); 15% of total procedures were performed in tandem with another extracorporeal support system (ecmo, cardiopulmonary bypass, crrt) as tpe for solid organ transplantation rejection. Ta was performed using one of three systems: cobe spectra ((b)(4)), spectra optia ((b)(4)) or therakos cellex. Ta is known for common minor adverse events including hypotension and hypocalcemia. In a pediatric population, these complications can be even higher, with up to 55% of procedures having an adverse event. The authors concluded that the low number (1. 6%) of minor adverse events for ta may be due to adherence to an institutional based protocol to mitigate citrate toxicity, which use slow citrate infusion increases and close calcium monitoring upon initiation of therapy. Their review demonstrated severe adverse events including seizure, pneumothorax, hemorrhagic stroke, and cardiac arrest in 3. 4% of our population and case mortality of 4%. Mortality data for those receiving ecmo in the pediatric population ranges from 16 to 45% across the international registry of ecmo support. 11 severe adverse events, including stroke, can occur in up to 12% of pediatric ecmo populations. Other common adverse events for ta including hypotension and anaphylaxis reactions were mitigated through embedded protocol orders employed at our institution. 9 automated electronic alerts were built into the hospital standardized order sets and alerted providers of any patient receiving medications, which could induce hypotension (e. G. , angiotensin-converting enzymes inhibitors). All patients had automatic orders to remain in bed at least 30 min post procedure, to reduce procedure related syncope. Automatic orders for heparin locks decreased the risk of clot and malfunction of lumens having intermittent access for apheresis procedures. Lastly, anaphylaxis kits were ordered to bedside during apheresis procedures to treat procedure complications from transfusion reactions. Citation: sirignano,? R.? M. , paden,? M.? L. , fasano,? R. , & meyer,? E.? K. (2017). Epidemiology of therapeutic apheresis with a multidisciplinary approach at a high volume pediatric center. Journal of clinical apheresis, 33(3), 297-302. Https://doi. Org/10. 1002/jca. 21604 investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[184720793]
A terumo bct employee identified an article by sirignano et al. Which describes a series of therapeutic apheresis procedures at a high volume pediatric center. The authors conducted a retrospective chart review of patients receiving therapeutic apheresis (ta) from january 1, 2012 through october 31, 2015. Data collected included demographics, american society of apheresis (asfa) indication, complications, and mortality. Over 46 months, 1198 procedures were conducted on 289 patients ranging in age from 5 months to 21 years with weights ranging from 4. 76 to 170. 3 kg (16 procedures in patients <10 kg). The procedures were 86% therapeutic plasmaexchange, 10% red blood cell (rbc) exchange, 4% extracorporeal photopheresis (ecp), and 5 leukocytapheresis procedures (lcp). Referral and initiation of ta occurred in a variety of care settings; 37% of the patients were critically ill in an intensive care unit (table 1); 23% of patients who were critically ill upon initiation of ta were in the cardiac (b)(6). Information regarding procedure related complications, procedure failures, procedure-related mortality, and case mortality was collected. Procedure complications were defined as any clinical issue, which occurred to the patient as a direct result of ta within a 24 hour period following the procedure. The rate of procedure failure and procedure-related mortality are 1 and 0%, respectively. Case mortality rate was 4%. There were no procedure related mortalities. While not procedure related, 4% of the patients did not survive to discharge home due to their underlying disease processes in the concurrent admissions. The disposable set is not available for return because it was discarded by the customer this report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00133 |
| MDR Report Key | 9872541 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| 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 | 2020-03-24 |
| 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 | 2020-03-24 |