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 2020-03-13 for SPECTRA OPTIA 10225 manufactured by Terumo Bct.
[188487253]
Lot number and expiry information are not available at this time. Investigation: patient had no past medical history. Patient was hospitalized for 3 months following myasthenia crisis, with chronic respiratory failure requiring tracheotomy and mechanical ventilatory support. The management of this refractory myasthenia was based on acetylcholinesterase inhibitors, corticosteroids, rituximab, and thymectomy. After a new relapse, daily tpes were started, with 4% albumin as the replacement fluid, which had a sodium concentration of 148 mmol/l and chloride concentration of 145 mmol/l. After the second saily tpe, the patient had a hyperchloremic metabolic acidosis reaction, so every other day tpes were started. Subsequent exchanges were spaced (every other day) and performed with less volume (1. 2 plasma volume). Laboratory tests performed after the next exchange showed an elevation of chloride at 110 mmol/l, but without significant acidosis. The analysis of substitution 4% albumin solution revealed a sodium concentration of 148 mmol/l and chloride concentration of 145 mmol/l. This acidosis is due to a reduction of the strong anion gap by an excessive rise of plasma chloride as well as a disproportionate renal bicarbonate elimination. Article citation: ritzenthaler, t. , grousson, s. , and dailler, f. Hyperchloremic metabolic acidosis following plasma exchange during myasthenia gravis crisis. Journal of clinical apheresis 31:479? 480 (2016). Published online 22 september 2015 in wiley online library (wileyonlinelibrary. Com). Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[188487254]
Per an article in journal of clinical apheresis, a myasthenia gravis patient was started on every-other-day therapeutic exchange procedures (tpe) following a hyperchloremic metabolic acidosis reaction on daily tpes. Laboratory tests performed after the next exchange showed an elevation of chloride at 110 mmol/l, but without significant acidosis. Is unknown at this time if medical intervention was required for the elevated chloride level. The disposable set is not available for return because it was discarded by the customer. This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00113 |
| MDR Report Key | 9830930 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-13 |
| 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 | 2020-03-13 |
| Catalog Number | 10225 |
| 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 | 2020-03-13 |