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

Catalog Number 10310

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Free or Unrestricted Flow (2945); Inadequate User Interface (2958)

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

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: per procedural cautions section of the spectra optia apheresis system essentials guide if the roller clamp on the saline line is left completely open when the patient is connected,the patient will be quickly infused with a large volume of saline.Per the machine, the total amount of fluids given: 1678 ac + 272 rinse back = 1950 ml.Total amount of fluids delivered by another method: 500 ml.Total fluids removed/collected: 220 mla calculation was performed by terumo bct and it was determined that the final fluid balance of the patient was 142%.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.

Event Description

The customer reported while performing a continous mononuclear cell (cmnc) collection on spectra optia for a patient with multiple meyeloma, they experienced issues with interface.The customer contacted terumo bct for troubleshooting.The customer stated that approximately 200 ml of normal saline was left in the 1 l saline bag.While troubleshooting, the customer discovered that she inadvertently left the saline roller clamp open.The support specialist instructed the operator to close the inlet saline roller clamp immediately and observed that the hct came back to 31% from entered value of 28% with cp of 50.There were no interface alarms reported and the customer indicated that the set was loaded correctly and the clamps were on the correct lines.The customer stated while sending back to the patient, they observed that there were cells in the collect port but too light.The customer therefore advised to lower the cp down to 45 and then to 40.Per customer, they continued with the procedure without any further issues.The patient is reported in the stable condition and no medical intervention was required.The customer declined to provide patient identifier (id).The cmnc disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in correction: bt clinical support discussed the importance of closing the saline roller clamp withthe operator and explained the impact an open saline roller clamp would have on the system whileestablishing the interface.Root cause: based on the customer statements and clinical findings, the root cause was relatedto the operator's failure to follow the screen prompt to close the inlet saline roller clamp at theend of prime divert.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8531562
• MDR Text Key: 146540400
• Report Number: 1722028-2019-00096
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

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: 01/01/2021
• Device Catalogue Number: 10310
• Device Lot Number: 1901183230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 05/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00059 YR
• Patient Weight: 112