SPECTRA OPTIA
Report
- Report Number
- 1722028-2017-00208
- Event Type
- Injury
- Date Received
- June 2, 2017
- Date of Event
- June 20, 2012
- Report Date
- June 2, 2017
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- PMA / PMN Number
- K103090
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE PHYSICIAN DETERMINED THAT NONE OF THE ADVERSE EVENTS WERE RELATED TO THE TREATMENT OF THE PATIENTS UNDERLYING DISEASE. ADDITIONALLY, PER INFORMATION PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE DEVICE DID NOT CONTRIBUTE TO ANY OF THE ADVERSE EVENTS. PER THE THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC LEUKOCYTAPHERESIS WITH A FREQUENCY OF 5.7% ACCORDING TO THE ARTICLE, 'LEUKOCYTE DEPLETION BY THERAPEUTIC LEUKOCYTAPHERESIS IN PATIENTS WITH LEUKEMIA', WBCD PROCEDURES ARE USED TO SYMPTOMATICALLY TREAT PATIENTS WITH HIGH WBC COUNTS THAT ARE THE RESULT OF AN UNDERLYING DISEASES, SUCH AS LEUKEMIA. THE ARTICLE SERVES AS A REFERENCE FOR ADVERSE EVENTS THAT CAN OCCUR AND SHOULD BE MONITORED FOR DURING A THERAPEUTIC LEUKOCYTAPHERESIS PROCEDURE. EXAMPLES OF CONTRAINDICATIONS FROM WBCD PROCEDURES LISTED FROM THE ARTICLE INCLUDE ANEMIA AND THROMBOCYTOPENIA. ADDITIONALLY, THE ARTICLE STATES THAT PATIENTS SHOULD BE ASKED ABOUT PARASTHESIA DUE TO HYPOCALCEMIA AND RECOMMENDS THEY RECEIVE CALCIUM SUPPLEMENTS. ALSO, CALCIUM AND POTASSIUM LEVELS SHOULD BE MONITORED AND CORRECTED BY INTRAVENOUS INFUSION, IF NECESSARY. FINALLY, THE ARTICLE RECOMMENDS CONTINUOUS MEASUREMENT OF HEART RATE AND BLOOD PRESSURE MONITORING IN THESE PATIENTS UNDERGOING LEUKOCYTAPHERESIS PROCEDURES. ROOT CAUSE: BASED ON THE RISK ASSESSMENT, LITERATURE REVIEW, CLINICAL FINDINGS, PHYSICIAN REVIEW,AND DLOG ANALYSIS, THE ROOT CAUSE FOR THE ADVERSE REACTIONS OF HYPOALBUMINEMIA AND THROMBOCYTOPENIA IS INCONCLUSIVE. POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO THE PATIENT'S DISEASE STATE AND/OR THE NATURE OF WBCD PROCEDURES. CITATION: HÖLIG, KRISTINA, AND RAINER MOOG. "LEUKOCYTE DEPLETION BY THERAPEUTIC LEUKOCYTAPHERESIS IN PATIENTS WITH LEUKEMIA." TRANSFUSION MEDICINE AND HEMOTHERAPY 39.4 (2012): 241-245.
INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. SIGNALS IN THE RDF CONFIRMEDTHAT THE SPECTRA OPTIA DEVICE OPERATED AS INTENDED AND NO SYSTEM OR DEVICE MALFUNCTION WASIDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. SIGNALS IN THE RDF CONFIRMEDTHAT THE SPECTRA OPTIA DEVICE OPERATED AS INTENDED AND NO SYSTEM OR DEVICE MALFUNCTION WASIDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
THE CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A WHITE BLOOD CELL DEPLETION (WBCD) PROCEDURE. APPROXIMATELY 2 HOURS POST PROCEDURE, THE PATIENT DEVELOPED DISSEMINATED INTRAVASCULAR COAGULATION (DIC), A FEVER, HYPOALBUMINEMIA, AND THROMBOCYTOPENIA. PER PHYSICIAN'S ORDER, A PLATELET TRANSFUSION WAS GIVEN TO THE PATIENT.
DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT'S AGE AND OUTCOME ARE NOT AVAILABLE FROMTHE CUSTOMER. PATIENT'S GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF).
DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT'S AGE AND OUTCOME ARE NOT AVAILABLE FROMTHE CUSTOMER. PATIENT'S GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389543 | SPECTRA OPTIA | SPECTRA OPTIA IDL SET | LKN | TERUMO BCT | 09T3119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |