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

Catalog Number 10220

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Based on the run data file analysis, the spectra optia system operated as intended.A service call was placed and a full machine checkout was performed.The machine is functioning per manufacturing specifications.An auto test, pressure check, and saline run were successfully performed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during prime of a red blood cell exchange (rbcx) procedure, the nurse noticed that the saline bag was empty.She discovered that she inadverently left the saline roller clamps open on the inlet and return line and the patient had received the full liter of saline.No medical intervention was necessary for this event and the patient did not require a follow-up visit.Per the customer, the procedure was completed and the patient was in stable condition.The customer declined to provide patient identifier.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the saline clamp being left open.Root cause: based on the information provided by the customer, not closing the clamps resulted in the additional saline being provided to the patient.The customer declined further use training, as the issue did not appear to be systemic.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 5140718
• MDR Text Key: 28378933
• Report Number: 1722028-2015-00577
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140191
• 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
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 10220
• Device Lot Number: 07Y3216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• 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: 17 YR
• Patient Weight: 99