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)

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

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation:per the rn, the saline roller clamp was on the correct line and they were able to complete the procedure.Total amount of fluids given: 1579 ml total amount of fluids delivered by other method: 700 ml total fluids removed: 387 ml final fluid balance: (b)(6) per the procedural cautions section of the spectra optia apheresis system essentials guide, states that 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.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: the clinical specialist spoke with the operator at the time of the incident regarding the importance of reading the screens and following the prompts to close the saline rollers when the machine prompts them.Follow up training is not required at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported while performing a continous mono nuclear cell (cmnc) collection procedure on spectra optia, they experienced issues with interface being low.The customer contacted terumo bct for troubleshooting.The customer stated they re established the access to the patient as they had the issues with the peripheral stick.The rn further stated they decreased hct from (b)(6) and the centrifuge was down for 25 minutes.While troubleshooting, the rn discovered that he inadvertently left the access saline roller clamp open and there was approximately less than 100mls of saline left in the saline bag.The support specialist instructed the operator to close the inlet saline roller clamp completely and to lower the hct further in order to get the interface into correct position to complete the procedure without any further issues.Per the customer the patient (donor) received approximately 700ml of normal saline.No adverse reaction was reported and no medical intervention was required.The customer declined to provide patient identifier (id).The cmnc collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in 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: 8359786
• MDR Text Key: 138135287
• Report Number: 1722028-2019-00038
• 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: 02/21/2019

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: 10/01/2020
• Device Catalogue Number: 10310
• Device Lot Number: 1810173230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 03/05/2019
• Supplement Dates FDA Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00022 YR
• Patient Weight: 100