MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-07 for SPECTRA OPTIA 12220 manufactured by Terumo Bct.
[178302511]
Investigation: a disposable history search was performed for lot 1910093330; no other similar issues have been reported. On (b)(6) 2020, service was performed on the optia 1p05097 machine at the customer site. A full autotest was performed with all tests passing. A saline run was successfully completed. Lock on was 100%. Average intensity 58%. The device was verified to be operating within manufacturer specifications. Investigation is in process. A follow up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[178302512]
The customer called with the alarm 'system continued to detect cells in plasma line from centrifuge' approximately 3 minutes into a therapeutic plasma exchange (tpe) procedure using a spectra optia device. The customer increased the hematocrit from 29% to 32% and described the plasma in the plasma line as being "mauve. " per the customer, hemolysis was also seen in the connector (cherry red) and waste bag (dark red). Initially, the physician stated that the patient was very sick and wouldn't doubt there was hemolysis. The procedure was continued because the physician didn't think the hemolysis was due to the system or disposable set. However, after continuing the run, the operator called customer support back with the physician. The physician stated the hemolysis may be related to the machine and wanted to stop the procedure. The physician also mentioned it could be related to the groin catheter because they were having problems on the continuous renal replacement therapy machine. The complete blood count (cbc) drawn at the beginning of the run was hemolyzed. A hemolytic panel for the day of the procedure was ordered. Per the operator it was tried to wash the blood off of the red port of the rij cath & r groin it didn't aspirate, but flushed well. She was told to use it anyway. The operator used the blue line for the inlet and the red line for return. This is the 3rd tpe procedure for the patient and the operator stated that the patient is worse now. The operator confirmed that the correct solutions (acda, 0. 9% normal saline) were attached and in the correct locations. No clots were observed in the channel or channel lines. Per follow up by terumo bct customer support on (b)(6) 2020, the nurse at the medical facility stated that the patient had coded and expired. Per the customer, the physicians determined the cause of death to be cardiac arrest with ventricular arrhythmia in the setting of severe anemia and hemolysis in a very sick patient who had a very poor prognosis irrespective of anything else. There was a temporal relation between the apparent hemolysis at the start of pheresis though it may have been related to the catheter (they had trouble with access pressures on crrt with that line previously) and not the pheresis disposable. The physicians declined to send the run summary, stating that they were confident this is a non-issue. No autopsy was performed. Per the customers physician, the overall cause of death was determined to be the patient's medical condition. This report is being filed due to patient death, though at this time, there is no evidence or allegation that the device caused or contributed to the patient death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00055 |
| MDR Report Key | 9683634 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-10-09 |
| 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 | 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 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 |
| Returned To Mfg | 2020-01-22 |
| Catalog Number | 12220 |
| Lot Number | 1910093330 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-02-07 |