MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-20 for SPECTRA OPTIA 10220 manufactured by Terumo Bct.
[184324358]
Lot number and expiry information are not available at this time investigation: per the article, "patients were classified into 4 categories as per the 2010 guidelines of american society for apheresis (asfa). Category i included indications where apheresis is accepted as a first line therapy; category ii when apheresis is accepted either as a solitary treatment or in conjunction with other treatment(s); category iii included disorders in which optimum role of apheresis therapy has not been established and category iv when published evidence demonstrates ineffectiveness or harm from apheresis... Tpe was performed for category i indications in 50%, category ii in 20%, category iii in 7% and category iv in 23% patients... The volume exchanged was as per the standard prescription for the indication in each category, as recommended by asfa guidelines. Fresh frozen plasma (ffp), isotonic crystalloids, cryo poor plasma and packed red cells constituted 62. 9%, 22%, 9. 9% and 5. 3% of plasma volume replacement respectively. " patient deaths in each asfa category: category i: 3 category ii: 2 category iii: 1 category iv: 4 the authors conducted a retrospective analysis of all patients (n = 56) who underwent tpe between may 2011 and august 2013. Data of demographic information, diagnosis, category of indication for tpe, number of tpe sessions, volume of plasma exchanged, type and volume of replacement solution infused, tolerance to tpe and outcomes in each category were analyzed (see data attachment containing table 2). Conclusion: the authors concluded that the intolerance to tpe was minimal in their study. One likely reason could be the relatively lesser use of plasma in their patient population. Clinical improvement was noted in 46 patients as judged by medical team providing care. Overall mortality rate in their study patients was 12. 5%/ 5. 35% of the procedures were aborted. The rationale for termination of procedures was not provided by the author article citation: ranganathan l, menon r, ramakrishnan n, venkatraman r, ramachandran p. Therapeutic plasma exchange practices in intensive care unit. Indian j crit care med 2019;23(7):336? 338. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[184324359]
Per an article by ranaganathan et al, therapeutic plasma exchange practices in intensive care unit in the indian journal of critical care medicine, a retrospective analysis was done on patients who underwent therapeutic plasma exchange (tpe) procedures between may 2011 and august 2013. There were 56 patients in the study. Demographics were: males 33 (58. 93%) females 23 (41. 07%); age (mean? Std. Dev) 43. 08? 16. 84. Seven patients in the study expired, though details of their deaths are not included in the article. Patient information and any treatment details for each of these patients was not provided. This report is being filed as a summary for the seven patients. 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 not an indication that the device caused or contributed to the patient death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00124 |
| MDR Report Key | 9860295 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-07-23 |
| 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 |