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

Model Number 70700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Reaction (2414)

Event Date 08/30/2016

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: kim, j, et al.2016.Comparison of spectra optia and cobe spectra apheresis systems¿ performances for red blood cell exchange procedures.Transfusion and apheresis science.2016.55:368-370.Investigation is in process.A follow-up report will be provided.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.(b)(4).

Event Description

In the article, 'comparison of spectra optia and cobe spectra apheresis systems¿ performances for red blood cell exchange procedures' (kim 2016), performance characteristics for isovolemic hemodilution (ihd-rbcx) procedures were compared in between cobe spectra and spectra optia devices.A total of 114 ihd-rbcx procedures from 19 patients (9 females with an average age 25.9, range 20¿39 and 10 males with average age 25.5, range 20¿34) were analyzed.For every patient, three procedures on each device with similar pre-procedure hematocrits were compared.57 procedures each were performed on cobe spectra and spectra optia.Chart review of the procedures in the study found 8 episodes of adverse events on the cobe spectra: 4 patients experienced parasthesia 3 patients experienced itching/hives 1 patient experienced hypotension the article does not describe what, if any, medical intervention was necessary for these events.Specific details regarding the patients that experienced adverse events, such as patient information and outcome, were not included in the article, therefore, this report is being provided as a summary of these events.The disposable set is not available for return because it was discarded by the customer.

Event Description

This was a retrospective clinical study to compare spectra optia and cobe spectra apheresis systems¿ performance for red blood cell exchange procedures involving nineteen patients (9 females with an average age 25.9, range 20¿39 and 10 males with average age 25.5, range 20¿34).A request for specific patient information is not feasible.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, d.4, h.6, and h.10, and corrected information in e.1.Investigation: according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Since this was a retrospective clinical study, the lot numbers are unkown.Since this was a retrospective clinical study to compare spectra optia and cobe spectra apheresis systems¿ performance for red blood cell exchange procedures, the lot numbers are unknown; therefore, a dhr search could not be conducted for the reported incident.All lots must meet acceptance criteria for release.Root cause: a definitive root cause for the patient reactions could not be determined.The reported hypotension is a common side effect of therapeutic apheresis procedures.It is typically caused by fluid shift, blood loss, length of the procedure, patient's sensitivity to the procedure and/or hemodynamic stress of the procedure.Possible causes for the alleged citrate reaction include but are not limited to ac management during the procedure, patient disease state, and/or patient sensitivity to anticoagulant.

• 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: 10414786
• MDR Text Key: 207557222
• Report Number: 1722028-2020-00383
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 35020583707000
• UDI-Public: 35020583707000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

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 Model Number: 70700
• 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: 02/01/2019
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 07/27/2022
• 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