MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA RBCX SET

Catalog Number 70700

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Coma (2417)

Event Date 11/29/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: per the customer, the operator made a simulated test on the machine by inputting the patient information to the machine again with the target hct as 40%.The procedure time was 40min; if set the target hct as 20%, then the procedure time was 104min.So the long duration time of this event might be caused by setting wrong target hct value.The operator stated that when the procedure had run for about 90 minutes, the remove volume was 1300 ml.The patient¿s hgb content was 220g before the procedure, but on the next day, the hgb content was 156g, the third day was 135g.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that 90 minutes into a red blood cell exchange (rbcx) procedure on a patient with polycythemia and vera hypertension, the patient reportedly felt sick and their blood pressure dropped.Then the patient fell into a coma.After treatment, the patient recovered consciousness, then experienced a cerebral infarction.Per the customer, the coma was not caused by excessive hemorrhage.The patient is now in stable condition.The customer declined to provide details about the medical intervention that was given.The patient identifier is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Event Description

The customer declined to provide the patient identifier.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.6 and h.10.Investigation: according to literature, polycythemia vera is a malignant disease belonging to the myeloproliferative neoplasms.The absolute increase in red blood cells (rbc) results in hyperviscosity and tissue hypoxia.Polycythemia vera patients are generally treated with isovolemic phlebotomy and low-dose aspirin, and high-risk patients require cytoreductive therapy.Repetitive phlebotomies gradually lower the disease-associated symptoms and the risk of thromboembolic complications.Some rare patients may present with severe microcircula tory symptoms or hemodynamic instability and require rapid lowering of the hematocrit.Erythrocytapheresis, like isovolemic phlebotomy, corrects the hyperviscosity by lowering the hematocrit value, but removes a higher erythrocyte volume than isovolemic phlebotomy and therefore reduces the time and number of procedures required to achieve the target hematocrit.Hence, it may be considered in hemodynamically unstable patients or in patients who require an efficient and fast decrease of red cell mass.[g.Stussia et.Al.Tra nsfus med hemother.2019;46:407¿416.] investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, h.6 and h.10 correction: regional clinical support verbally retrained the operator on the correct set up for rbcx procedures.Root cause: based on the customer's findings during their internal investigation, the longer than anticipated procedure time was likely due to an incorrect target hct entry of 20% instead of 40%.With a hct target of 40%, the system calculated a procedure time of 40 minutes; however, with a hct target of 20%, the system calculated a procedure time of 104 minutes which was close to the actual procedure time.The cause of the reported coma and subsequent stroke could not be determined.The customer clarified that coma was not caused by excessive hemorrhage.It is possible that the additional processing of blood led to cellular depletion and/or a hypovolemic state which contributed to the adverse events.; however, based on the limited information provided, there was not enough to confirm this and it cannot be ruled out that the medical emergency, and the continuous drop in the patient's hematocrit was caused by the patient's disease state.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA RBCX SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11046994
• MDR Text Key: 223358563
• Report Number: 1722028-2020-00561
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 70700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 04/14/2021; 07/12/2021; 11/24/2021
• Supplement Dates FDA Received: 05/06/2021; 08/02/2021; 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00073 YR
• Patient Sex: Female
• Patient Weight: 58 KG