MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA IDL SET

Catalog Number 10310

Device Problems Defective Alarm (1014); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); Hypervolemia (2664)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer reported that the displayed fluid balance (fb) from the spectraoptia device was 125% and the anticoagulant citrate dextrose solution a (acd-a) given to the patient was 1423 ml.225 ml of total fluids removed from the patient during the procedure.The calculated ending fb was 143%.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection on aspectra optia device they received an 'interface took too long to establish' alarm.Uponinspection, it was found that the inlet saline roller was left open and the patient received anadditional 1000ml of saline as a result.Prior to contacting the terumo bct support line, theoperator reduced the patient hematocrit from 29% to 23%.Per the customer the patient is instable condition.The customer declined to provide patient indentifier (id).The spectra optia exchange set is not available for return because it was discarded by thecustomer.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: root cause for the open saline clamp was determined to be due to user error as confirmed by the customer.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 8170492
• MDR Text Key: 131792955
• Report Number: 1722028-2018-00348
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2018

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 Expiration Date: 10/01/2020
• Device Catalogue Number: 10310
• Device Lot Number: 1810173230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 01/10/2019; 01/28/2019
• Supplement Dates FDA Received: 01/11/2019; 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2018
• 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: 00045 YR
• Patient Weight: 86