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

Catalog Number 12220

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670)

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

Event Date 12/22/2018

Event Type  malfunction  

Manufacturer Narrative

At this time lot number, expiration date and manufacture date are unavailable.Investigation: per the customer, they cannot be sure how much blood may have come into the machine and how much plasma might have been removed in the exchange procedure.Furthermore, the customer reported that the fact that 3l saline was used and the nurse thought that there was no blood going in to the set for the first 45 minutes suggests that less than 4l plasma was removed and the patient¿s heavy diuresis during the next 6 hours (output jumped from ~50ml/h to ~400ml/h) and fall in hct and hgb supports their conclusion that the albumin infusion into the set was not matched by an equal volume of plasma being removed from the patient.The customer reported that the fibrinogen drop could have been due to clotting factors being removed with the plasma, but could also have been due to haemodilution.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a thrombotic thrombocytopenic purpura (ttp) patient was undergoing a therapeutic plasma exchange (tpe) procedure on the spectra optia machine with a 4.0l plasma exchange (pex) against 5% human albumin.After connecting the patient, the nurse forgot to close the saline clamp and reported noticing that blood was not being drawn into the disposable set.This continued for the first 45 mins of the procedure, and in the last 30 mins some blood was noting coming into the set.Per the nurse, the patient was given 4l of albumin over a total period of 1h 20min.The nurse reported that the saline bag had emptied and she replaced it twice during the procedure, using a total of 3l of saline.The patient¿s haematocrit and hemoglobin fell from 40 to 28% and ~115 to ~80g/l respectively post exchange.The fibrinogen fell from 1.6 to 0.9g/l and the patient experienced heavy diuresis during the next 6 hours.As a result of the fibrinogen drop, the patient was supplemented with fibrinogen concentrate.The patient is reported as having normal cardiac and renal function post procedure and seems not to have been negatively affected.Patient information is not available at this time.The 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 and corrected information.Per terumo bct medical review, the device (operator error) contributed to the outcome of the reported event.Root cause: based on the customer's description and the analysis of the run data file, the root cause was attributed to the operator's failure to follow the screen prompt to close the inlet saline roller clamp at the end of prime divert.Correction: terumo bct sales consultant for therapeutic systems retrained two of the operators on the importance of following the screen prompts, especially after alarm occurrences.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information is being provided.Investigation: terumo bct performed a calculation using data provided by the customer and it was determined that the final fluid balance for the patient was 162%.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The procedural cautions section of the spectra optia apheresis system essentials guide, states that if the roller clamp on the saline line is left completely open when the subject is connected,the subject will be quickly infused with a large volume of saline.Investigation is in process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information in.Investigation: the run data file (rdf) was analyzed for this event.Review of the images along with the rdf and customer complaint indicates that the operator left the inlet saline line open causing the interface to have trouble setting up since saline was entering the system.In the images the interface was not visible due to the excess saline entering the system.The procedure received the ¿aim system could not establish target interface¿ alarm.The ¿aim system could not establish target interface alarm is triggered when the interface takes longer to establish than the system expects.On the alarm screen, there are several possible causes for why the alarm may have been triggered and including the saline line being left open.An internal tbct software issue tracker was initiated and approved to include an alarm to alert operators of open clamps on the return line in sw version 12.1.Investigation is in process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.Patient gender and weight were obtained from the run data file (rdf).

• 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: 8276263
• MDR Text Key: 136246681
• Report Number: 1722028-2019-00023
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 12220
• Device Lot Number: 1803293230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 02/05/2019; 02/22/2019; 03/29/2019
• Supplement Dates FDA Received: 02/15/2019; 03/12/2019; 04/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2018
• 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: 78