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

Catalog Number 12320

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591); Gas/Air Leak (2946)

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

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6): per the customer, the nacl roller clamps were on the correct lines and closed correctly.One used optia idl disposable set contained with blood was returned to terumo bct for investigation.Upon initial observation, it was noted that the ac and saline drip chambers had been rf sealed and removed prior to return.Blood is present throughout the cassette, in return reservoir and channel.The inlet and return saline roller clamps were observed to have been assembled correctly and were in the closed position.The disposable set was visually examined for any kinks, missing parts or any other misassembly and none were found.Flow throughout the tubing set was also verified, with no occlusions observed.The run data file (rdf) was analyzed for this event.And,review of the dlog confirmed the patient's tbv to be 3366ml with a total procedure time of 27 minutes.Patient stats:total amount of liquid administered by the device (indicated):69 ml total amount of liquid administered by the device (measured): > 500 ml volume of nacl bag : 500 ml assuming 1000ml bag, final fb 132% investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that approximately 6 minutes into a continous mononuclear cell (cmnc) collection procedure on spectra optia, they received an ¿inlet pressure low¿alarm and after 28 minutes ¿inlet pressure sensor malfunctioned¿ alarm occured.The customer noted that the normal saline bag was empty and there was air in the tubing set.Per customer, they stopped the pump and pressed 'stop' key to clear the ¿leak in centrifuge¿ alarm.Subsequently,¿ low-level reservoir sensor did not detect fluid ¿ alarm occurred.The procedure was terminated and a new set was installed to restart the procedure.Per the customer, no medical intervention was required for this event.Patient identifier and outcome are not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information in adverse event problem and additional mfr narrative.Corrected information is provided in initial reporter name and address.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.The signals in the rdf indicate that the spectra optia system operated as intended.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 patient is connected, the patient will be quickly infused with a large volume of saline.Root cause: based on the customer's description of events, 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.

Manufacturer Narrative

This report is being filed to provide additional information in the event investigation is in process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient id and outcome are not available from the customer.

Manufacturer Narrative

This report is being filed to provide updated information in investigation: further evaluation of this event has determined that the device did not causeor contribute to a death or serious injury, nor is there a likely potential for death or serious injuryassociated with this event based on additional investigational information.It was confirmed thatthe final fluid balance (fb) of the patient was actually 117% ,after receiving the full 500ml of thesaline bag and 69ml of ac.Corrected investigation:patient stats: with an initial tbv of 3367ml, the final fb of the patient was actually 117% afterreceiving the full 500ml of the saline bag and 69ml of ac.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Correction: retraining was offered to the customer on (b)(6) 2019.As of (b)(6) 2020, no response from the customer has been provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9098168
• MDR Text Key: 165083045
• Report Number: 1722028-2019-00272
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• 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,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 12320
• Device Lot Number: 1906153231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 09/24/2019; 10/28/2019; 12/13/2019; 01/07/2020
• Supplement Dates FDA Received: 10/15/2019; 11/08/2019; 12/20/2019; 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00020 YR
• Patient Weight: 47