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

Catalog Number 000000000000010220

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Venipuncture (2129)

Event Date 01/11/2014

Event Type  malfunction  

Event Description

The customer reported that approximately 50 minutes into a therapeutic plasma exchange(tpe) procedure, the rn noticed the plasma in the connector and plasma line was pink colored.A physician was called and the physician gave orders for a cbc and to discontinue the procedure.Per the customer, the patient is in stable condition and no medical intervention was necessary.Patient's identifier is not available at this time; the customer declined to provide patient's weight.The disposable set is not available for return because it was discarded by the customer.This report is being filed due to insufficient information at this time to determine if a malfunction with the potential for injury occurred.

Manufacturer Narrative

Investigation: the rn performed custom prime for the procedure.409ml of plasma were removed and 383 ml of fresh frozen plasma was replaced during the procedure.The rn called the lab to find out the plasma color of the cbc sample.The lab sample was normal yellow plasma.On the following day, a new disposable set was loaded and the procedure was completed without any additional incidents.Investigation evaluation and corrective actions are in-process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A review of the lot for similar reports was carried out, none have been reported.The run data file (rdf) was analyzed for this event.Root cause: based on the rdf analysis, after a ¿cells were detected in plasma line from centrifuge¿ alarm, operators are supposed to increase the patient¿s hct by (b)(6) points, up to (b)(6) points above the originally entered value.The operator originally decreased the patient¿s hct in this case.The opposite of what they should have done and then increased it, but not by the correct amount.

Event Description

The customer declined to provide the patient identifier.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information to align with the reported event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3612593
• MDR Text Key: 4094433
• Report Number: 1722028-2014-00038
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2014

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: 11/01/2015
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 11V3226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2014
• Initial Date FDA Received: 02/07/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/29/2014; 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2013
• 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: 15