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

Catalog Number 10310

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Overdose (1988); No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer stated that the patient pre cd34+ count was 56 on day 2 of cmnc collection procedure.The customer also stated that they used 15 mg of calcium gluconate as part of the standard operating procedure at the customer¿s site and the patient received 1781ml of anti-coagulant (ac).The patient¿s fluid balance was calculated to be 133% at the end of the procedure.The run data file (rdf) was analyzed for this event.Signals in the rdf showed that the optia system operated as intended throughout the procedure.Signals in the rdf indicated that an¿interface took too long to establish¿ alarm occurred early in the procedure.The ¿interface took too long to establish¿ alarm is triggered when the aim system is not able to detect an interface when it expects it to be present based on the patient¿s entered data.Common causes for this alarm include an inaccurately entered patient hematocrit, an obstruction in the collect line below the collection bag, or in the collect or plasma lines below the cassette, or an incorrectly loaded channel.The alarm screen directs the operator to confirm that the patient¿s entered hematocrit is accurate, that there are no obstructions in the collect or plasma lines, and that the channel is fully loaded in the filler.The alarm screen suggests that the operator decrease the patient¿s hematocrit by three percentage points to adjust the interface position.The operator made the correct adjustment in this case by decreasing the patient¿s hematocrit from 31% to 28% after the alarm occurred, however the hematocrit was changed back to 31% several minutes later.Root cause: based on the customer's statement, the cause of the unintended delivery of saline was an open inlet saline line clamp.The clamp was unintentionally left open during the procedure, despite the operator's confirmation on the screen display that the clamp was closed.

Event Description

The customer reported that a patient was undergoing day 2 of a continuous mononuclear cell(cmnc) collection procedure.Approximately 10 minutes into the procedure, they received an ¿interface took too long to establish¿ alarm.While the operator adjusted the patient¿s hematocrit by 3 from the spectra optia display screen while troubleshooting, she discovered that she had inadvertently left the inlet saline roller clamp open and the patient received an additional 200ml of saline bolus.It is unknown at this time if medical intervention was required for this event.Patient¿s age and outcome are not available at this time.The cmnc 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 ine.1.

Event Description

The customer stated that no medical intervention was required for this event.The customer did not respond to multiple attempts to obtain patient's age.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6926618
• MDR Text Key: 90209771
• Report Number: 1722028-2017-00391
• Device Sequence Number: 1
• Product Code: GKT
• 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
• Report Date: 10/06/2017

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: 05/01/2019
• Device Catalogue Number: 10310
• Device Lot Number: 05A3104
• Other Device ID Number: 05020583103108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/07/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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
• Patient Weight: 65