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

Catalog Number 10310

Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: total amount of fluids collected (per machine): 223ml; total amount of fluids given by machine (per machine): 1115ml; other fluids given: calcium gluconate iv = 321ml, ns flushes 80ml.Anticoagulant (ac) bag volumes=750mls / normal saline (ns)= 1000mls.2 bags of ac were used, 1 bag of ns used.Ns: 100 - 200 mls left in the bag at the time of customer call.Customer admitted the patient received a lot of saline when trying to resolve inlet pressure alarms.This diluted the patient¿s blood and caused subsequent 'interface taking too long to establish' alarms.Per the customer, the patient¿s tbv was 4785 ml and they used a 1l bag of saline.Assuming the worst case scenario of having 100 ml saline left in the bag as observed by the operator, the patient¿s fluid balance at the time of the call is calculated as 118.9 % investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a continuous mononuclear cell (mnc) collection procedure,they had some 'inlet pressure' alarms, and while trying to resolve these alarms, the patient received "a lot" of saline.Total amount of fluids collected (per machine): 223ml; total amount of fluids given by machine (per machine): 1115ml.The patient is in stable condition following the event.The customer declined to provide the patient identifier.The collection set is not available for return.

Manufacturer Narrative

This report is being filed to provide additional information: the run data file (rdf) was analyzed for this event.Signals in the rdf indicated that the system operated as intended.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in evaluation codes and additional mfr narrative.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.In the procedural cautions section of the spectra optia apheresis system essentials guide, it 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 statement, she had inadvertently left the inlet saline roller clamp open and this was the root cause of the 'interface took too long to establish' alarm.The operator closed the clamp and spiked another bag of saline.She was able to establish the interface and complete the procedure after closing the inlet saline roller clamp.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5954580
• MDR Text Key: 55217711
• Report Number: 1722028-2016-00524
• 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
• Report Date: 09/15/2016

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: 07/01/2018
• Device Catalogue Number: 10310
• Device Lot Number: 07Z3122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/06/2016; 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2016
• 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 Age: 00034 YR
• Patient Weight: 95