MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for SPECTRA OPTIA 10220 manufactured by Terumo Bct.
[187866768]
Lot number and expiry information are not available at this time. Investigation: per the article, there were four technical errors detected. Three involved centrifugation sets manufacturing defects, and one involved error in centrifugation set installation. Adverse events were graded according grading adapted from the swedish apheresis group. Adverse events were graded as mild (grade i) in 5. 3% (13/245), moderate (grade ii) in 2. 0% (5/245) and severe (grade iii) in 2. 0% (5/245). Grade i requires no medical intervention. All vascular accesses were by a temporary double lumen central venous catheter. In kilograms. Patients were pre-loaded with 500 ml of normal saline to ensure adequate hydration and volume before each procedure. The blood pump speed was set between 40 and 120 ml/min. Intravenous 1 g calcium gluconate was infused during tpe as standard protocol. Replacement fluids were 2/3 albumin 5% in hartmann? S solution and remaining 1/3 with normal saline crystalloids solution. Vital signs monitoring every 15 min during the procedures with a cardiac monitoring were performed as standard observation protocol (15? 30 min intervals). All patients had internal jugular catheter inserted for tpe under ultrasound guidance. Symptomatic hypocalcemia associated with the acid-citrate-dextrose solution use was observed in 5 of the patients, while allergic reactions associated with the use of transfused human albumin such as rashes and nausea were reported in 1 patient. There was no potentially life-threatening complications or procedure-related mortality occurring among our cohort of patients. Four incidences involving technical errors were noted by tpe staffs while performing the procedures; three were due to centrifugation set manufacturing defects, resulting in inability to initiate procedures (two sets) and procedure termination due to high pressure error (one set). Another technical glitch was due to error in centrifugation set installation onto the machine. The high centrifugation frequency resulted in a crack at the tubing set, with subsequent blood leak and visible contamination in the rotating separation chamber. No report of adverse event affecting the patient was noted. They performed further pearson? S correlation analysis to search for associations of tpe complications with procedure parameters (baseline weight, pre-procedure hct, number of tpe cycles and exchanged pv). They found only higher pv exchange was significantly associated with crbsi (p=0. 023). Although the exchanged pv was based on formula calculated with patient? S body weight and pre-procedure hct, both parameters were not independently a factor for higher infection risk. Similarly, we found no different in average hct among the group of patients who developed hypotension and those who did not (37% vs 37%, p=0. 889). Number of tpe cycles was not associated with the incidence of infection. No tpe parameter was found to be associated with hypotension, hypocalcaemia and allergic reaction. However, we experienced slightly higher rates of hypotension (4. 9%) secondary to fluid shift compared with the reported rates at 0. 4%? 4. 2%. This could be attributed to the use of a less vascular expansion fluid replacement regime of human albumin 70% and crystalloids 30% compared with 100% human albumin. Majority of the hypotensive events were handled by reducing inlet flow rates and infusion of crystalloid saline. Article citation: fu ks, wong py, hiew fl. Therapeutic plasma exchange (tpe) for semi- critical neurology presentations in a non- acute neurology set- up: clinical practice and challenges. Bmj neurology open 2020;2:e000020. Doi:10. 1136/ bmjno-2019-000020 investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[187866769]
Per the article, 'therapeutic plasma exchange (tpe) for semi- critical neurology presentations in a non- acute neurology set- up: clinical practice and challenges' in bmj neurology open by fu et al, both adverse events and "technical errors" are described, which occurred during therapeutic plasma exchange (tpe) procedures with spectra optia. The study was performed between may 2015 and june 2018. A total of 245 tpe procedures were performed in 55 patients for nine neurological indications, predominantly the central nervous system (79%). There were 16 (29%) men and 39 (71%) women with median age of 41 years old (range 13? 63). The median weight of patients was 56 kg there were five moderate (intervention required; treatment completed) adverse reactions and five severe (procedure interrupted or abandoned) adverse reactions. Hypotensive episodes during tpe were the most commonly reported events. All patients responded to either with reduction of inlet flow rates, intravenous hydration, or cessation of tpe procedure. One event required commencement of intravenous infusion of vasopressors. Hypocalcemia and allergic reactions were also reported. Exact patient data, outcomes, and any treatment for reactions is not provided in the article, therefore this report is being filed as a summary of the 10 reported patient reactions. 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 | 1722028-2020-00127 |
| MDR Report Key | 9860383 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-19 |
| 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 |
| 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 |