MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-07 for SPECTRA OPTIA 10225 manufactured by Terumo Bct.
[186020523]
Investigation: the run data file (rdf) was analyzed for this event. Review of the run data file showed that the? Low-level reservoir sensor detected excess fluid? And the? Air was detected in return line? Alarms were generated at 49 minutes into the procedure. The operator did correctly press the? Air removal? Button and proceed to perform the air removal process. During the air removal process, the system pumps approximately 20ml of saline from the saline container into the reservoir to displace the air from the return line back into the reservoir and vent bag. However, two minutes into the process, the? Reservoir was full during air removal? Alarm occurred, and the operator had to discontinue the procedure. This alarm can occur if there are multiple alarms occur within a short period of time or there is an air block in the plasma line so extra fluid was diverted to the reservoir causing it to fill to the high-level sensor sooner than expected and generate the safety alarm. Possible causes for the? Air was detected in return line? Alarm include, but are not limited to: - tubing is not correctly seated in the return pump (which can cause the return air line detector (rlad) to detect air instead of fluid in the tubing) - foam or air in the return line - defective return line air detector - machine issue investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[186020524]
The customer reported that during a therapeutic plasma exchange (tpe) procedure on a spectra optia device using albumin with 37? C heater, air bubbles were seen in the return line. Per the customer the procedure was ended when the air was seen. Patient identifier and outcome are unknown at this time. The exchange 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 | 1722028-2020-00054 |
| MDR Report Key | 9682332 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2019-09-24 |
| Date Added to Maude | 2020-02-07 |
| 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 | 2020-02-07 |
| Catalog Number | 10225 |
| Lot Number | 1909233230 |
| 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 | 2020-02-07 |