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.
[188577291]
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. Number of tpe cycles was not associated with the incidence of infection. 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 every15 min during the procedures with a cardiac monitoring were performed as standard observation protocol (15? 30min intervals). All patients had internal jugular catheter inserted for tpe under ultrasound guidance. 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. The number of patients who developed crbsi was low with no life-threatening events seen. All bacteremia responded to intravenous antibiotic therapies. With pre-procedure, serum calcium check and infusion of 1 g calcium gluconate during tpe as standard treatment protocol, citrate anti-coagulant-derived symptomatic hypocalcemia (paresthesia, nausea and emesis) were uncommon at our center. In addition, the risk was further reduced by having human albumin and crystalloids as fluid replacement instead of ffp. 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
[188577292]
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 six instances of catheter-related blood stream infection (crbsi) following insertion of the central venous catheter. These events were not life threatening and all bacteraemia responded to intravenous antibiotic therapies. Exact patient data, outcomes, and any treatment for the crbsi is not provided in the article, therefore this report is being filed as a summary of the 6 reported crbsi cases. 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 | 1722028-2020-00126 |
| MDR Report Key | 9860382 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| 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 |
| 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; 2. Required No Informationntervention | 2020-03-20 |