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

Catalog Number 10220

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: fluid hanging were0.9% normal saline, anti-coagulant (acda), 5% albuminthe customer stated that the procedure was going well until the neurology physician adjustedthe patient¿s neck.After the patient¿s neck was adjusted, they received multiple access.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure, they received multiple alarms including 'cells detected in plasma line from centrifuge' alarm and noted red tinge in the plasma line and connector that they described as hemolysis.The rn stopped and disconnected the patient.The patient is reported in stable condition.The customer declined to provide the patient identifier.The tpe set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: a definitive root cause could not be determined.It is possible that the observed blood tinged plasma was due to an interface spillover based on the customer statements that the hct was not updated and also other customer statements that the patient moved his neck with access problems following.Additionally, the rn reported seeing a clear separation/interface in the plasma and red cell layers which does not indicate an issue with hemolysis during the procedure.Possible causes for spillovers include but are not limited to patient condition causing cells to prematurely exit the chamber, inaccurate entry of the patient's hematocrit, and/or variable inlet flow rate.The customer also stated they thought the plasma was blood tinged because of the plasma trying to pass through an observed clot at the connector tubing.It is possible, though not conclusive, that the blood tinged plasma was hemolysis possibly caused by a partial occlusion from the clot or other disposable occlusion.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: during customer follow-up, the customer stated there was no issues with the machine.The unit coordinator at the customer's site stated that the operator was new and did not read or perform the troubleshooting suggestions provided from the spectra optia's display screen on the machine.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.Investigation: during customer follow-up the customer stated that the procedure was performed again on (b)(6) 2017 without any incidents.Investigation is in process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCAHNGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6647252
• MDR Text Key: 77844781
• Report Number: 1722028-2017-00243
• 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,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: 10220
• Device Lot Number: 04A3126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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: 00027 YR
• Patient Weight: 72