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 10120 manufactured by Terumo Bct.
[185752300]
Lot number and expiry information are not available at this time. Investigation: the article states: "because platelet clumping can necessitate multiple adjustments to the baseline apheresis instrument settings to avoid irreversible clotting in the collection set, it was of interest to determine whether run parameters required adjustment tha ultimately would increase adverse reactions in the patient or decrease ce or hsc product cd34+ cell yield. Many factors, such as patients? Underlying disease, mobilization regimen, blood contact with artificial surface, and centrifugal speed of the instrument, can contribute to platelet clumping in apheresis systems. Potential patient- specific factors include the production of procoagulant proteins and high levels of inflammatory cytokines in patients with myeloma12 as well as the increased thrombin generation and fibrin formation seen in healthy donors who received filgrastim mobilization. In addition, our hypothesis is that young, large platelets from recovering/regenerating hematopoietic systems (mainly chemotherapy mobilization) are more likely to be activated and might lead to clumping in the apheresis system during collection. Platelet clumping was observed in 63% of collections. Multivariable analysis revealed that a lower white blood cell count was an independent predictor of clumping occurrence. Chemotherapy mobilization and a lower peripheral blood cd34 + cell count were predictors of the degree of clumping. Procedures with clumping had higher collection efficiency but lower blood volume processed on average, resulting in no difference in collection yields. Citrate toxicity did not correlate with clumping. " article citation: mathur, gagan, et. Al. 2017. Factors influencing platelet clumping during peripheral blood hematopoietic stem cell collection. Transfusion. 2017 may ; 57(5): 1142? 1151. Investigation is in process. A follow up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[185752301]
In the article 'factors influencing platelet clumping during peripheral blood hematopoietic stem cell collection', published in the journal transfusion, a study was done to document the incidence of platelet clumping during collections, evaluate its impact on patient adverse events and product hematopoietic stem cell (hsc) yield, and identify factors associated with platelet clumping. In total, 258 hsc collections performed on 116 patients using the optia mnc protocol were reviewed. Per the article, "collections were performed using the spectra optia mnc protocol (terumo bct) with ac citrate dextrose (acd-a) containing heparin (6 units heparin/ml acd-a) to allow for large-volume collections while minimizing the risk of citrate reactions. In general, the collection was stopped when 30 l of wb was processed or after a 5- hour run time, whichever occurred first. Central venous access was used if peripheral access was not possible or was not preferred by the donor. The collections were performed at maximum draw speed of 100 ml/minute for peripheral venous access and 125 ml/minute for central venous access" the article states that "measures taken to mitigate symptoms of citrate toxicity (tingling, numbness, cramping) included slowing the wb flow rate and calcium supplementation with milk products or calcium carbonate. In the event of severe cramping, intravenous calcium gluconate was administered. No prophylactic calcium was administered intravenously during collections. No moderate or severe adverse events unrelated to citrate toxicity were noted during the hsc collections. " this report is being filed for the citrate toxicity events that necessitated medical intervention in the form of iv calcium gluconate. The article did not specify number of occurrences, or any patient information for these events, so this report is being submitted as a summary of these events. 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 | 1722028-2020-00138 |
| MDR Report Key | 9888653 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2017-05-01 |
| Date Mfgr Received | 2020-03-02 |
| 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 | 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 COLLECT SET |
| Product Code | LKN |
| Date Received | 2020-03-27 |
| Catalog Number | 10120 |
| 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 | 2020-03-27 |