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

Catalog Number 10220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Anxiety (2328); Sweating (2444)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4), investigation: per customer, inlet flow rate was 120ml/min during the first procedure and90ml/min during the second procedure.The volume of ac given to the patient during 1st procedure was 428ml and 306 ml during the 2nd.The 500ml bolus was done on the basis of the ironcology apheresis protocol order set.The attending rn stated just prior to this event the primary rn had performed a finger stick on the patient.She explained that the patient has a history of becoming very anxious just having a finger stick or seeing any blood.Customer maintains the reaction was caused from the patient's anxiousness.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypotension is one of the most common reactions associated with apheresis and is usually well tolerated.The following progression is often observed: pallor and sweating begin, with the skin turning cold, the pulse slows strikingly, the blood pressure decreases, followed by nausea.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.

Event Description

The customer reported that a guilliane barre (gb) patient with a history of high anxiety and panic attacks developed hypotension during a therapeutic plasma exchange (tpe) procedure on (b)(6) 2019.Approximately 10 minutes before the end of the procedure, patient experienced sweating, nausea and became pale.The patient's blood pressure decreased from 104/64 to 86/56.The operator performed the rinse back and per protocol, they administered abolus of 500 ml of normal saline (ns) intravenously to the patient.The rn stated patient as anxious and recovered well and was doing fine.Two days later ((b)(6) 2019), the rn stated that another tpe procedure was performed on the same patient using the patient's ideal body weight as (b)(6) lb plus 30% without any reaction symptoms or decrease in blood pressure.The patient was reported in stable condition.The customer declined to provide the patient identifier (id).The 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 h.6 and h.10.Investigation: per the customer, the 500ml bolus is part of the customer's oncologyapheresis pre-order set.According to spectra optia operators manual under general proceduralcautions :the spectra optia system has many safety features.However, a patient reaction canoccur rapidly.Therefore, it is imperative that the operator monitor the patient and the systemthroughout the procedure and be prepared to take appropriate action.Per the spectra optia concepts of anticoagulant, the spectra optia system calculates thepatient¿s tbv using the nadler and allen nomogram, which is appropriate for normal healthyadults only.For patients less than 25 kilograms, or for patients with unique circumstances(pregnancy, obese patients or amputees), the physician should determine an appropriate tbv.On subsequent follow up,it was found that the following value was used on the procedureheld on 01/16: tbv based on ideal body weight of 278 lb = 7516 mlper the terumo bct field performance team (fpt) on the basis of end of run values, thesystem computed ac infusion rate and actual ac infusion rate were calculated for the firstprocedure.The ac infusion rate and the patient's tbv are used to determine the ac dosethat can be infused to the patient in ml/min.Increases in the ac infusion rate results in agreater volume of ac delivered to the patient and increases the potential for the patient toexperience a citrate reaction.For procedure 1, where the system calculated a tbv of 10.189 l based on the actual bodyweight, height, and gender entered, the estimated ac infusion rate was calculated to be1.17 ml/min/l tbv: 1492ml of ac/125min/10.189l = 1.17 ml/min/l tbvthe adjusted ac infusion rate for procedure 1 can be calculated using the tbv calculatedbased on the ideal body weight and was determined to be 1.59 ml/min/l tbv:1492ml of ac/125min/7.516l = 1.59 ml/min/l tbvany ac infusion rate higher than 1.2 ml/min/l tbv would place the system into caution statusdue to the ac infusion rate exceeding the recommended maximum rate; whereby, the cautionstatus alerts the operator that the system is operating outside of certain established limits witha yellow line appearing on the bottom of the screen.However, in this case, the systemassumed a higher tbv based on the height, actual weight, and gender entered and not alower tbv based on ideal body weight.Therefore, the system assumed that the ac infusionrate was within the safety limits and did not generate an alert.The end of run report from 1/14/19 indicated that the initial plasma volumes exchanged wastargeted at 1 but the procedure was ended after 0.9 plasma volumes was exchanged (5366ml plasma removed).The patient received a total of 428 ml ac with an extended run time of125 minutes due to larger tbv processed.The end of run report from 1/16/19 indicated that the final plasma volumes exchanged was 1and a total of 4356 ml plasma removed.The patient received a total of 306 ml ac with areduced run time of 96 minutes due to smaller tbv processed.Due to the use of non-ideal body weight to calculate the patient's tbv, the patient receivedan additional 122 ml of ac during the course of the first procedure.The most recent preventive maintenance was performed on 19nov2018.A fliud check andautotest were sucessfully completed and the device was verified to be operating withinmanufacturer specification.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in investigation: per terumo bct medical review, it was determined that the device did notcause or contribute to the reported event.Per analysis, these ac infusion rate values are all wellbelow the default control limit of 0.8 ml/min/ltbv and neither was used to control theprocedures.The post-procedure records in the screen shots show that the initial (planned)average inlet flow rate (inlet processed/procedure time) for the first procedure was 119.6 ml/minand the final (actual) was 119.4 ml/min.For the second procedure the initial and final averageflow rates were 119.8 and 117.6, respectively.This suggests procedures were controlled by inletflow rates, with a possible slowing of the rates during parts of the second procedure.Root cause: based on the clinical findings, investigation, and medical review a specific rootcause could not be determined.The possible causes of the patient's reaction include the patient'sdisease state with the associated autonomic defects in blood pressure control and/or anxietyinduced by the finger-stick and tpe procedures.Corrected investigation: for procedure 1 the optia system calculated a tbv of 10.189 lbased on the actual body weight the estimated ac infusion rate is calculated to be 0.336ml/min/ltbv: 428 ml of ac/125min/10.189l = 0.336 ml/min/ltbvthe adjusted ac infusion rate for procedure 1 can be recalculated using the tbv calculatedbased on the weight entered for procedure 2 (278 lb) and was determined to be 0.456ml/min/ltbv: 428 ml of ac/125min/7.516l = 0.456 ml/min/ltbvthe calculation for procedure 2 (306 ml acd-a in 97 minutes with a tbv of 7.516 l) gives an acinfusion rate of 0.420 ml/min/ltbv.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8321315
• MDR Text Key: 135695526
• Report Number: 1722028-2019-00031
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2019

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: 11/01/2020
• Device Catalogue Number: 10220
• Device Lot Number: 1811053230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 03/07/2019; 05/06/2019
• Supplement Dates FDA Received: 03/29/2019; 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00028 YR
• Patient Weight: 209