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 2020-01-10 for SPECTRA OPTIA 12220 manufactured by Terumo Bct.
[174531393]
Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[174531394]
The customer reported that following disconnection of a pediatric guillian barre patient from a therapeutic plasma exchange (tpe) using a spectra optia device, the patient expired. Per the customer, after approximately 17 minutes, they received and alarm for an "aim failure". The aim site was deactivated by the instruction of terumo bct support. The customer reported multiple alarms of "inlet pressure too low". A tbct technical service engineer gave instructions by telephone to the customer about the process for handling alarms. The call was ended when the head nurse at the customer site decided to end the procedure and disconnect the patient. Upon follow up with the customer an hour later when the clinical specialist arrived at the hospital facility, the customer reported that the patient expired due to respiratory arrest. Patient age, gender, and weight are not available at this time. This report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction. The disposable set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
[177885467]
Investigation: the autopsy report is not available per the customer. The run data file (rdf) was analyzed for this event. Review of the rdf and images for this procedure showed that there were multiple access pressure alarms and aim system alarms throughout the run that likely contributed to procedure being ended earlier than expected. Given this information, signals in the dlog indicated that the machine operated as intended and was operating within the safety limits programmed in the machine. In total, there were 51 inlet pressure alarms during the procedure. The most common source of pressure alarms is when the inlet flow rate is set too high for the given patient access or the patient access is not properly positioned. In response to these alarms, it is suggested to check the positioning of the patient access and lower the inlet flow rate. The inlet flow rate ranged from 25-133ml/min throughout the run. The operator did initially reduce the inlet flow rate in response to the alarms; however, they subsequently increased it later on, resulting in additional alarms. Ensuring the patient access is appropriately sized, nothing is blocking the access, the inlet flow rate is not too high, and generally controlling access issues is important as these can greatly contribute to the success of a procedure. The? Aim system did not detect interface? Alarm occurred early in the run and is triggered when the aim system is unable to determine where the interface is within the connector within a specific timeframe. This alarm can be generated if the patient hematocrit was entered too high, the channel was not loaded correctly, or there was debris on the connector or filler. The operator did lower the entered hematocrit however it was then increased back to the initial value shortly afterwards. Six minutes later, the centrifuge door was opened, presumably to check loading of the set in the filler. Upon restarting the system, the? Aim system did not complete interface measurement? Alarm was generated numerous times. This alarm is generated when the aim system does not receive images as expected. As this alarm continued to occur, this was an indication that the aim system failed and was not receiving images. The operator disabled the aim system and continued the procedure in semi-automatic mode as recommended on the alarm screen. However due to multiple inlet/return pressure alarms and other issues, the operator ended the run shortly after. For both aim alarms generated during the run, the online alarm screen instructions recommend contacting your bct service representative to evaluate the system before beginning a new procedure. The aim system is not required to successfully complete therapeutic procedures. If necessary, procedures may be run in semi-automatic mode or with aim completely disabled to achieve the required treatment. Further dlog review of other procedures performed on this device, both before and after the incident date, confirmed successful runs where intended targets were met. On 12/17/2019, the terumo bct service technician responded to multiples alarms during procedure aim system could not establish target interface and inlet pressure was too low. Call support was carried out verifying the status of the procedure with the user, and there are no failures that may be generating the low inlet pressure. Possible couplings, obstructions, kit installation, centrifuge opening were checked with no reported issues. Preventive maintenance was performed on optia 1p04558 on 12/27/2019, which included a general inspection, system check and calibration, electrical safety and power test, fan test, sealer maintenance, and pump occlusion tests. The lower strobe rail voltage was adjusted from 48% to 55. 33%. The device was verified to be operating per manufacturer specifications. The device history record (dhr) was reviewed for this lot. There were no issues related to the event experienced by the customer identified in the dhr. A disposable history search found no other reports of similar issues associated with lot 1906263230. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2020-00018 |
| MDR Report Key | 9575275 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-01-10 |
| 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 | 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 EXCHANGE SET |
| Product Code | LKN |
| Date Received | 2020-01-10 |
| Catalog Number | 12220 |
| Lot Number | 1906263230 |
| 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 | 2020-01-10 |