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

Catalog Number 10220

Device Problems Improper Flow or Infusion (2954); Inadequate User Interface (2958)

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

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

Lot number, expiry and manufacture date are not available at this time.Investigation: a tpe set contained with blood and the blood warmer tubing was returned toterumo bct for investigation.Upon visual inspection, it was noted that both roller clamps were open, the red pinch clamp was closed, the blue pinch was open and the slide clamp on the bloodwarmer tubing was closed.Blood was also noted in the return and inlet saline lines from themanifolds through the cassette and in the saline line above the cassette which indicated thatrinseback was completed.The roller clamps were inspected and confirmed that the roller clamps occluded the tubing properly.The tpe set was also visually inspected for kinks, occlusions,misassembly, missing parts and other manufacturing defects which may have contributed to theissue and none were found.The run data file (rdf) was analyzed for this event.Signals in the rdf showed that the optiasystem operated as intended and is safe to use.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure, the rnnoticed that the saline bag was empty.The saline roller clamps were checked and ensured they were closed.While another bag of saline was hung up, she noticed that blood was diverting into the saline bag.She was able to resolve the free flow of saline by clamping the return salineline.Per the rn, approximately 200 to 400ml of saline was given to the patient.No medicalintervention was required for this event.The customer stated that the procedure wassuccessfully completed and the patient tolerated the procedure well.The patient is reported instable condition.The customer declined to provide patient identifier.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a calculation was performed to determine patient's final fluid balance.Based on the provided information by the customer, the patient's final fluid balance was calculated as 128%.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: root cause of the unintended delivery of additional saline was that the clamp was unintentionally left open for a time during the procedure.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation is in process.A follow-up report will be provided.

• 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: 6630506
• MDR Text Key: 77549487
• Report Number: 1722028-2017-00231
• Device Sequence Number: 1
• Product Code: LKN
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2017

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: 03/01/2019
• Device Catalogue Number: 10220
• Device Lot Number: 03A3208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 12/12/2017; 04/08/2018
• Supplement Dates FDA Received: 12/12/2017; 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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: 00003 YR
• Patient Weight: 18