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

Catalog Number 10310

Device Problems Accessory Incompatible (1004); Excess Flow or Over-Infusion (1311); Defective Component (2292); Device Operates Differently Than Expected (2913)

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

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer stated that on the spectra optia display screen, it indicated that 477 ml of fluid was delivered to the patient.Per the customer, additional 1705 ml of saline was given to the patient during the procedure.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a white blood cell (wbc) depletion procedure they used 2 bags of normal saline.During troubleshooting, the nurse confirmed both saline roller clamps were closed and on the correct lines.The nurse placed a hemostat on the inlet saline line and the drip stopped.The procedure was continued with the hemostat in place.The customer reported that the patient tolerated the rest of the procedure well and is in stable condition.Patient id, age and weight are not available at this time.Terumo bct is awaiting return of the depletion set for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: total amount of fluids machine gave (displayed): 477 ml (1310 ac used -899 removed -16 tubing set -49 saline diverted + 131 rinseback)¿ total amount of fluids machine gave (measured): none¿ total amount of fluids delivered by other method (specify type and amount): 1705 (253 ecv +42 blood warmer -1000 ns prime) = 705 ml ns left in ns bag after prime + 1000 ml additional saline given = 1705 ml¿ total fluids removed/collected (displayed): 899 ml¿ total fluids removed/collected (measured): none¿ patient/donor initial tbv: 5764 ml based on the values listed above the total fluid balance calculation = 137% (6241 + 1705ml =7946/5764 = 137%).Root cause: based on the evidence found during the returned part investigation, the root cause for the continuous drip on saline clamp was determined to be due to a defective roller clamp.The operator was able to complete the procedure using a hemostat in addition to the roller clamp.

Manufacturer Narrative

This report is being filed to provide additional 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.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a used spectra optia disposable set was returned for investigation.Upon visual inspection, it was noted that the red roller clamp on the inlet saline line had the white roller sitting just inside the open end.The roller was not contained within the housing track and damage was observed along the sides.One side of the roller was broken off and worn down, making it unloadable within the housing track.The broken component fragment was not found within the returned bag.The return roller clamp was found undamaged and was obstructing the fluid flow correctly.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

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

Event Description

The customer declined to provide patient identifier (id).

• 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: 7194851
• MDR Text Key: 98069226
• Report Number: 1722028-2018-00014
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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,Followup,Followup
• Report Date: 01/16/2018

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: 05/01/2019
• Device Catalogue Number: 10310
• Device Lot Number: 05A3331
• Other Device ID Number: 05020583103108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 02/05/2018; 04/10/2018; 08/10/2018; 10/10/2018; 11/01/2018
• Supplement Dates FDA Received: 02/09/2018; 04/20/2018; 08/10/2018; 10/19/2018; 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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: 59 YR
• Patient Weight: 96