MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 61000

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry are not available at this time.Investigation: per the customer, the ac infusion rate was (b)(6).Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a collection procedure for transplant, the donor information was entered incorrectly.Per the customer, the patient did fine, no problems with the collection and they were able to collect enough cells for a transplant.Entered weight of patient: (b)(6) entered height of patient: (b)(6).Calculated total blood volume (tbv): 4901 ml actual weight of patient: (b)(6) actual height of patient: (b)(6).Actual calculated total blood volume (tbv): 4596 ml.Patient id and age are not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide corrected information in d.1, d.2, d.4, d.10, h.4, h.5 and h.8.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10, and corrected information in h.5 and h.8.Investigation: the terumo bct clinical specialist advised the operator to call customer support with any questions or issues with a procedure suggested that patient data always be double checked by a second operator to make sure it was entered correctly.Root cause: the root cause of the incorrect patient data entry was operator error, as well as a failure of the second operator to double check the patient data.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the operator stated that the ac infusion rate was 0.8 ml/min/ltbv, which is below the maximum ac infusion rate of 1.2 ml/min/ltbv allowed on the optia system.Calculations indicate the patient received 3.9 ml/min of ac when the system used the incorrect tbv value of 4901 ml, as opposed to 3.7 ml/min of ac they would have received if their actual tbv of 4596 ml had been used, resulting in a 5% increase of ac.Amount of ac to the patient per system calculation of tbv = 4.901 l tbv x 0.8 ml/min/ltbv = 3.9 ml/min adjusted amount of ac to the patient for their actual tbv = 4.596 l tbv x 0.8 ml/min/ltbv = 3.7 ml/min one year of service history was reviewed for this device with no issues related to the reported condition identified.The device serial number history report indicates no further related issues have been reported for this device.Investigation is in process.A follow up report will be provided.

Event Description

The customer declined to provide patient identifier and age.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10385594
• MDR Text Key: 209430896
• Report Number: 1722028-2020-00372
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Device Catalogue Number: 12320
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 10/15/2020; 11/13/2020; 12/08/2020
• Supplement Dates FDA Received: 10/15/2020; 11/30/2020; 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70