MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-02 for SPECTRA OPTIA 61000 manufactured by Terumo Bct.
[186735383]
Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[186735384]
The customer reported that a patient received more anticoagulant citrate dextrose solution a (acd-a) during a therapeutic plasma exchange (tpe) on a spectra optia device thank expected. Per the customer, 33 mls more of acd-a was used on the procedure than had been used a few days prior on the same patient during the procedure. Following a conference call between the patient's doctor and the customer, it was noted that the patient's actual weight was entered on (b)(6) 2019, which was higher on this day due to having excess body fluid. Per the customer the patient also receives dialysis. Patient information and outcome are unknown at this time. 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 | 1722028-2020-00004 |
| MDR Report Key | 9540407 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2017-10-13 |
| Date Added to Maude | 2020-01-02 |
| 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 | GARY DARK |
| Manufacturer Street | 10810 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3035425102 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRA OPTIA |
| Generic Name | SPECTRA OPTIA APHERESIS SYSTEM |
| Product Code | LKN |
| Date Received | 2020-01-02 |
| Model Number | 61000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-02 |