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

Catalog Number 10220

Device Problems Partial Blockage (1065); Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

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

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

Per the customer, the treating physician ordered a complete blood count(cbc), comprehensive metabolic panel (cmp), type and screen of the patient and testing set andrbc unit in case of replacement fluid incompatibility or transfusion reaction.Per the rn, hemolysistesting was not performed.During follow up with the rn, it was reported that the physician at the customer site had performed a central line check and the line was found to be causing re-circulation, which the physician determined was the cause of the pink plasma.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 a 'cells were detected in plasma line from centrifuge' alarm during thelast unit of a red blood cell exchange procedure (rbcx) on a spectra optia device.Per the rn,the color of the plasma line exiting the centrifuge was pink and the rn clarified that the plasmawas not this color from the start of the procedure.No clots were observed in the channel orchannel lines.The terumo bct clinical specialist advised the nurse to stop the procedure andcontact the treating physician to determine if hemolysis was related to the patient's condition.The physician stopped the procedure as a precaution, despite the patient being asymptomatic.The patient was reported as asymptomatic and was up and walking around after theprocedure.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: per the physician's statement, the root cause of the hemolysis was re-circulation in the central line, which allowed the blood to enter the optia system multiple times, leading to lysis of the red blood cells.The placement of the catheter was confirmed to be out of position.As a result, this caused an occlusion of the intake line inside the duel lumen catheter.Per terumo bct's medical review, the device did not cause or contribute to this incident.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 8199322
• MDR Text Key: 132388182
• Report Number: 1722028-2018-00360
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172590
• 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
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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: 10220
• Device Lot Number: 1810223130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2018
• 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: 16 YR
• Patient Weight: 29