MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-14 for SPECTRA OPTIA 12220 manufactured by Terumo Bct.
[185699340]
Investigation: the customer provided terumo bct customer support with photographs of the connector and the front of the machine, from which the tbct customer support specialist could see hemolysis in the connector and plasma line. The plasma in the plasma line was a cherry color. A disposable history search was performed for lot 1911123130. One other similar issue was reported by the same customer. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[185699341]
The customer reported that 3 minutes into a therapeutic plasma exchange (tpe) procedure on a pediatric patient, they received the alarm 'cells were detected in plasma line from centrifuge'. The operator stated that she performed custom prime with red cells; the patient's tbv is 952ml. This patient has history of developing clots, so she is on heparin. The operator was having issues with the access line which was very positional. The operator stated that the replacement fluid is fresh frozen plasma (ffp) and the type is compatible. The patient has had a heart transplant and she has tpe procedures twice per week; today is the first treatment of the week. The operator stated that no clots were visible in the channel or set. The patient did not receive any hemolyzed components form the channel or the reservoir. The physician asked the operator to terminate the procedure, set up the machine again, perform a custom prime, and continue. No other labs were ordered by the physician and no testing was ordered on the unit or the patient. No medical intervention was required for the patient after the terminated procedure. The operator stated that the patient did great in the second procedure. They did not send the blood prime unit for testing, but they determined the alleged hemolysis was likely related to the blood from the custom prime that was in still in the channel at the time it was observed. The patient is in stable condition. The customer declined to provide the patient identifier. 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 | 1722028-2020-00062 |
| MDR Report Key | 9711534 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2019-11-12 |
| Date Added to Maude | 2020-02-14 |
| 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 | 2020-02-14 |
| Catalog Number | 12220 |
| Lot Number | 1911123130 |
| 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 | 2020-02-14 |