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

Catalog Number 10220

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993); Optical Discoloration (2999)

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

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, deglycerized red cell units was used as replacement fluid.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that approximately 40 minutes into a red blood cell exchange (rbcx) procedure, they received a ¿cells detected in the plasma line from the centrifuge¿ alarm and noted that the plasma line was amber colored.The rn contacted the physician and the physician gave orders to end the procedure.Per the customer, no medical intervention was required and the patient is reported in stable condition.The customer declined to provide patient identifier.The rbcx set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event, therefore device history record (dhr) review for all 11 lots shipped to this customer for 6 months prior to the incident date was performed and 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.Investigation: the customer stated a deglycerized red cell unit had been used as a replacement fluid.According to (b)(6) md in the article "cellular cryopreservation in blood banking", aabb standards call for the removal of the cryoprotective agent to ensure minimal hemolysis.If the residual glycerol exceeds 1%, hemolysis may occur when it is brought in contact with plasma.Significant hemolysis may occur because of poor technique or abnormal hemoglobins.Root cause: a definitive root cause for the reported amber plasma is not determined.Possible causes include but are not limited to: plasma color seen is actually a spillover during procedure and not hemolysis, plasma color seen is hemolysis related to hemolyzed rbc replacement solution used from diglycerol process, plasma color seen is hemolysis related to misload of the set, or plasma color seen is related to patient physiology/disease state.Citation: (b)(4).

Event Description

The customer declined to provide additional procedural details and lot number for this event and no further testing was conducted by the customer to determine if hemolysis was present.

• 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: 6647383
• MDR Text Key: 77932416
• Report Number: 1722028-2017-00244
• 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: 06/16/2017

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 Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: 04/04/2018; 04/18/2018
• Supplement Dates FDA Received: 04/13/2018; 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 00034 YR
• Patient Weight: 68