MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-06 for SPECTRA OPTIA 10220 manufactured by Terumo Bct.
[182287722]
Investigation: per the customer, autopsy results are not available. The equipment was checked out by terumo bct technician. A visual inspection was performed and no problems found. A complete simulated saline run with a tpe set was performed with no problems with the run or the equipment. There is no problem found with the equipment. Equipment has been checked out and is ready to be placed back into service. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[182287723]
The customer reported that about 7 minutes into the therapeutic plasma exchange (tpe) procedure, the patient's temperature started to drop and then the blood pressure. They stopped the procedure and started to code the patient. The patient then expired. The customer does not suspect the device caused the event. The disposable set is not available for return because it was discarded by the customer. This report is being filed due the patient death, however, it is not alleged or suspected that the device caused or contributed to the patient death.
Patient Sequence No: 1, Text Type: D, B5
[182476372]
Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[182476373]
Patient id is not available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00090 |
| MDR Report Key | 9796558 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-08 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-12-12 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| 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 | 2020-03-06 |
| Catalog Number | 10220 |
| Lot Number | 1912123230 |
| 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 | 2020-03-06 |