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

Catalog Number 10220

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

Investigation: during customer follow-up, the customer stated that they had a discussion withthe rn who performed the procedure.The rn stated that the saline roller clamps were closedand they received no alarms prior to the start of the procedure.The rn also stated that they didnot bolus through the machine and the machine was turned off prior to opening the clamps.The run data file (rdf) was analyzed for this event.Signals in the rdf showed that the optiasystem operated as intended.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately 10 minutes into a therapeutic plasma exchange (tpe) procedure, a patient suffered a seizure.During the procedure, the patient¿s hemoglobin dropped from 9 g/dl to 6 g/dl and blood was noted in the saline bag.Per the customer, the rn stopped the procedure, checked the patient¿s vital and fluids were provided.The rn contacted the emergency team and the patient was transported to the emergency department.Per the emergency team¿s order, the patient was transfused with 2 units of red blood cell (rbc).The customer stated that the patient is ¿fine¿ and is reported in stable condition.The customer declined to provide patient identifier (id).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 in investigation is still in process.A follow-up report will be provided.

Manufacturer Narrative

The customer provided a photo of the saline bag.Upon photographic inspection, it was observed that the saline bag was 'ballooned' and contained a large portion of blood.It was also observed that the drip chamber and saline line are both filled with blood.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: the customer provided a photo of the saline bag.Upon photographic inspection, it was observed that the saline bag was 'ballooned' and contained a large portion of blood.It was also observed that the drip chamber and saline line are both filled with blood.Upon photographic inspection, the status of the return saline roller clamp (open/partially open/closed) cannot be confirmed.However, for that volume of blood to have reached the saline bag the roller clamp would have needed to be at least partially open for a portion, if not all, of the procedure.Additionally, based on the volume in the saline bag, it is suspected that the return line pinch clamp was not opened when prompted by the system resulting in no fluids being returned to the patient and all fluids being pumped into the saline bag through the open/partially open saline roller clamp.Based on the end of run summary, an estimate of the volume that would have been pumped into the 500 ml saline bag can be made ¿1283 ml.Use testing was performed and confirmed that a 500 ml bag is capable of holding this volume of additional fluid, and has a similar appearance to the image provided by the customer.It was noted during use testing that towards the end of the bag filling the resistance became higher.Therefore, the return line pinch clamp was likely closed during the procedure.This would have resulted in the patient experiencing rapid blood loss, approximately of 31% of the patient tbv.Additionally, the procedure itself would not have been responsible for the drop in hg in the patient as no fluids were returned to the patient.The drop in hg can be explained by the bolus of fluids, presumably saline, provided to the patient when the event occurred prior to transfer to the er.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Tatany or seizure incidents occur in 0.2% of procedures.Per terumo bct's medical review, the device did not cause or contribute to this incident.Root cause: the root cause of the drop in hg was the bolus of fluids provided to the patient when they started to have seizure during the procedure.The root cause of the seizure could not be determined.Possible causes include, but are not limited to:-operator error in clamping resulting in rapid blood loss due to the return line pinch clamp being closed and fluids routing to the saline bag through the open saline roller clamp.Patient disease state or underlying condition.

• 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: 6972809
• MDR Text Key: 90071084
• Report Number: 1722028-2017-00410
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 10220
• Device Lot Number: 1708083130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2017
• 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; Required Intervention
• Patient Age: 00020 YR
• Patient Weight: 65