MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET,EA

Catalog Number 10220

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the investigation, use of d5w (5% dextrose in water solution), instead of albumin/saline for replacement fluid, has the potential for inducing hyperglycemia in the patient.Per internal risk review, the residual total risk level is low for this event.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.Correction: a terumo blood and cell technology specialist offered retraining to the customer on 08/04/2020.The customer declined training as they stated the known user error was recognized internally.Root cause: based on the clinical findings, the root cause of the use of an incorrect replacement fluid was operator error.

Event Description

The customer called because during a therapeutic plasma exchange (tpe) procedure on a myasthenia gravis patient using a spectra optia device, the customer realized d5w (dextrose solution) was hung as replacement fluid.Per the customer it is normal practice to for this customer to use a combination of saline and albumin for stable patients but in this case, the operator mistakenly hung d5w instead of saline.It was confirmed that the machine was not primed with d5w.The customer stated that only 6 mls of d5w had passed over the replacement pump.The terumo bct support specialist advised the customer to abort the procedure without rinseback.Per the customer the device was reset up and the patient was treated with a fresh set, with no further issues were reported.Per the customer the patient is stable with no consequences to patient.The disposable set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10381411
• MDR Text Key: 202212598
• Report Number: 1722028-2020-00369
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/14/2020
• 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: 58 YR
• Patient Weight: 94