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

Catalog Number 10120

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591); Inadequate User Interface (2958)

Patient Problems Hypervolemia (2664); No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacturer date and expiry date are not available at this time.Investigation: the customer reported that the operator was new to apheresis, and this is why the open roller clamps were not noticed right away.Per customer, the roller clamps were on the correct lines, but the red inlet saline roller clamp was opened.The run data file (rdf) was anaylzed for this event.The signals in the rdf show that the fluid flowing through the set was very light and clear.The signals show that it was not blood flowing through the set, most likely saline.The most common cause of this is leaving the inlet saline roller clamp open and the pumps pull saline through the set instead of the patient's blood.Collect volume: 40 mlac in collect bag: 6 ml patient blood volume processed: 4625 ml fluid balance: 590 ml (112%)ac to patient: 510 ml saline to patient: 101 ml investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a monomuclear cell collection (mnc) procedure on anallogenic donor they received 'interface taking too long to establish' alarms and used 3 bags of 500ml normal saline (ns) in 120 minutes.The customer had already contact terumo bct customer support for assistance with the alarm and lowered the hct, as well as lowered the ac ratio.Per the customer, the return saline roller clamp was closed and on the green saline line and the inlet saline roller clamp was opened and on the green saline line.Tbct customer support explain that both roller clamps were supposed to be closed during the run and this resulted in the extra saline to the patient.The customer reported that they disconnected the patient because the donor couldn't be on the machine any longer per their site protocol.They performed rinse back to the donor and contacted the physician.The medical director at the customer site requested for the donor to come back in to run a renal panel.Patient id, age, weight and outcome are not available at this time.The collection 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 is provided.Investigation: after multiple follow-up attempts, the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The procedural cautions section of the spectra optia apheresis system essentials guide, page 11, states that if the roller clamp on the saline line is left completely open when the patient is connected, the patient will be quickly infused with a large volume of saline.The calculated final fluid balance was determined to be 143%.Correction: the customer was aware of the error and clinical support had discussed the error with the customer at the time of the call.Since multiple attempts to contact the customer resulted in no response, no further training could be conducted specific to this incident.Root cause: based on the clinical findings, the root cause was related to the operator's failure to follow the screen prompt to close the inlet saline roller clamp at the end of prime divert.

Event Description

After multiple follow-up attempts, the customer did not respond to request to provide patient info, outcome, if a renal panel was completed or further procedural details for this event.

Manufacturer Narrative

Investigation: upon further evaluation of the run data file (rdf), it was determined that there were eleven (11) "interface took too long to establish" alarms.This is due to the fluid flowing through the channel not being dark, as blood should be, in the beginning of the procedure.There were also eight (8) "return pressure was too high" alarms and nine (9) "centrifuge pressure exceeded limit" alarms.A blood warmer was also in use during this procedure.The optia device operated as intended and it was determined that the operator left the inlet saline clamp open and that was the cause of the reported issue.Investigation is in process.A follow- up report will be provided.

Manufacturer Narrative

This report is being filed to provide information that was not provided in the initial mdrsubmission for this event.Investigation is in process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECTION SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9128972
• MDR Text Key: 164635386
• Report Number: 1722028-2019-00280
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 75