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

Catalog Number 12220

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); Hypovolemia (2243)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they were performing a therapeutic plasma exchange (tpe) on a liver failure infant.The ecv was indicated as 300ml as this is their minimum, however in reality it was around 230 ml.The device was prefilled with an ery concentrate.Due to the mismatch of the ery concentrate and the patient hematocrit (hct), and slow inlet speed, the device took a long time to find an interface.The hct was adjusted upwards to support finding th interface ealier as the rbcs had likely increased the patient¿s hct.Key issue was the alarm that the patient¿s fluid balance had exceeded (min.) fluid values during the procedure.Despite setting a 100% fluid balance, the procedure ended up with a negative fluid balance (90%).To compensate, at the end of the procedure, a partial rinceback (20 ml) was given.This number should have been around 50ml, but there was a misunderstanding between the physician and operator(s).The customer reported that there were no negative effects to the patient.Patient identifier and age are not available at this time.The disposable 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 h.6 and h.10.Corrected information is provided in h.1.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Final fluid balance was determined to be 86% and there was no report of an adverse consequence, thus no medical intervention was required.The final fluid balance was adjusted for the actual tbv of the patient (210ml - based on the attached procedure data sheet), and was calculated to be 86%.(210ml-30ml)/210ml = 0.857 x 100 = 86% correction: the terumo bct customer representative discussed the findings of the investigation with the customer by phone due to covid-19 site visit restrictions.Root cause: review of the run data file showed that the ¿predicted fluid balance exceeded limits¿ alarm occurred initially after the operator enabled rinseback for this procedure.With a very small tbv as entered for this procedure, small changes to the procedure can cause big impacts on the fluid balance for the small tbv patient.The ¿predicted fluid balance exceeded limits¿ alarm occurred because toggling rinseback on would cause the system to go more negative during the procedure to accommodate the extra fluid returned during rinseback.Later during the procedure, the system received a ¿patient's fluid balance may be 5% lower than reported¿ alarm during the procedure.Again, because of the low tbv of the patient, this alarm may occur if the system detects less fluid than expected is entering the reservoir.This may occur due to normal pump variation for smaller patients.Ending the procedure early is what led to the fluid balance at 90%.The operator ended rinseback after about 19ml were returned to the patient.There was still about 30ml that needed to be returned.Had the operator allowed rinseback to complete, the end fluid balance would have been 100% as set by the operator earlier in the procedure.

Manufacturer Narrative

This report is being filed to provide additional information in b.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf showed that the ¿predicted fluid balance exceeded limits¿ alarm occurred initially after the operator enabled rinseback for this procedure.With a very small tbv as entered for this procedure, small changes to the procedure can cause big impacts on the fluid balance for the small tbv patient.The ¿predicted fluid balance exceeded limits¿ alarm occurred because toggling rinseback on would cause the system to go more negative during the procedure to accommodate the extra fluid returned during rinseback.Later during the procedure, the system received a ¿patient's fluid balance may be 5% lower than reported¿ alarm during the procedure.Again, because of the low tbv of the patient, this alarm may occur if the system detects less fluid than expected is entering the reservoir.This may occur due to normal pump variation for smaller patients.Ending the procedure early is what led to the fluid balance at 90%.The operator ended rinseback after about 19ml were returned to the patient.There was still about 30ml that needed to be returned.Had the operator allowed rinseback to complete, the end fluid balance would have been 100% as set by the operator earlier in the procedure.Investigation is in process.A follow up report will be provided.

Event Description

Pursuant to eu personal data protection laws, the patient identifier and age are not available from the customer.

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.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
• MDR Report Key: 9972414
• MDR Text Key: 189715509
• Report Number: 1722028-2020-00172
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2001033130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 3