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

Catalog Number 10220

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914); Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: fluids hanging were acda and 0.9% normal saline (ns) per the customer, fresh frozen plasma (ffp) was used as a replacement fluid and the patient was given heparin earlier in the day.The customer stated that the patient was on a continuous veno-venous hemofiltration (cvvh) and extra corporeal membrane oxygenation (ecmo) during the procedure.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 a ¿cells detected in the plasma line from centrifuge¿ alarm and noted red tinge in the plasma that they described as hemolysis.The rn was unable to resolve the alarms, therefore, she ended the procedure and disconnected the patient.The customer declined to provide the patient identifier.The therapeutic plasma exchange (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.During follow-up with the customer, they stated that the procedure was performed again on the following day on the same machine and no hemolysis was detected.Root cause: a definitive root cause could not be determined.Although root cause was inconclusive, possible causes include the following, based on customer's statements review:- hemolysis due to an occlusion in the disposable set- hemolysis due to pharmacy error in saline/replacement solution, use sterile water instead of saline.According to the article, 'unexplained hemolysis in patients undergoing ecmo: beware of hypertriglyceridemia' the researchers explains how hemolysis is a common complication of extracorporeal membrane oxygenation (ecmo) support and per the physician, the reported patient was being treated in the icu due to his complex disease state.Citation: venado, a, et al."unexplained hemolysis in patients undergoing ecmo: beware of hypertriglyceridemia." perfusion, vol.30, no.6, 2014, pp.465¿468.,doi:10.1177/0267659114557693.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Investigation: 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.The signals in the rdf indicate that the spectra optia system operated as intended.Investigation is in process.A follow-up report will be provided.

• 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: 6646945
• MDR Text Key: 77940293
• Report Number: 1722028-2017-00240
• 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

• 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: 04A3205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• 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: 00017 YR
• Patient Weight: 76