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

Catalog Number 10220

Device Problems Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Date 08/12/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: this patient received the tpe procedure immediately after undergoing a secondary processing device (spd) exchange procedure during which hemolysis also occurred.This event was reported on mdr #1722028-2016-00504.Consequently, it is suspected that the hemolysis that was observed during the spd procedure was still present in the patient at the time they initiated the subsequent tpe procedure.This residual free plasma hemoglobin remaining in circulation from the spd procedure caused the early onset of alarms on the tpe procedure.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Signals in the rdf support the reports of hemolysis for this procedure.The rdfs do not point to a conclusive root cause for alarms that signaled possible hemolysis and subsequent hemolysis, however, it is believed that the optia device was operating as intended by alarming and the likelihood of exchange set defect contributing is unlikely.Root cause: the rdf analysis and customer's response indicates that the spectra optia device and spectra optia disposable are not the cause for the hemolysis observed.The root cause for the observed hemolysis in this tpe procedure is related to the spd procedure that occurred immediately before the tpe procedure on the same patient.The rdf analysis indicates that the hemolysis that was observed during the prior spd procedure was still present in the patient at the time they initiated this tpe procedure.

Event Description

The customer reported that one minute into a therapeutic plasma exchange (tpe)procedure, they observed hemolysis.The operator terminated the procedure at this time.The customer declined to provide patient identifier and age.Patient's gender and weight were obtained from the run data file (rdf).The spectra optia exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in initial reporter.The initial reporter declined to provide a contact telephone number.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5931118
• MDR Text Key: 54024077
• Report Number: 1722028-2016-00505
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: 10220
• Device Lot Number: 02Z3217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• 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 Weight: 95