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

Catalog Number 10310

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Inadequate User Interface (2958)

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

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry are not available at this time.Investigation: the customer stated that on the spectra optia display screen, it indicated that 1732 ml of anti-coagulant (ac) and 172 ml of saline was delivered to the donor.Per the customer, additional 750 ml of saline was given to the donor during the first minutes 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 collection.There were 5 ¿interface took too long to establish¿ alarms during this run.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.The fact that the inlet saline line was not clamped during a portion of the procedure when the system expected it to be explains why the system was having difficulty building up the interface.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a donor from (b)(6) was undergoing a continous mononuclear cell (cmnc) collection procedure.During the procedure,the operator received 'interface took too long to establish¿' alarms and noticed that the spectra optia system was not collecting cells.While the operator was troubleshooting, it was discovered that the inlet saline roller clamp was inadvertently left open for approximately 3 liters into the collection.The operator closed the inlet saline roller clamp and successfully completed the procedure.No adverse reactions occurred in this event.Per the customer, the donor tolerated the procedure well and was discharged from the customer site.Patient (donor) (b)(6)the cmnc collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf indicated that the fluid balance reported on the spectra optia system is 1469ml and the patient's tbv is 4918ml.Patient's actual fluid balance was calculated as 146%.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the customer statement, root cause of the hypervolemia is due to the operator inadvertently leaving the saline line clamp open.Signals in the run data file showed that the optia system operated as intended throughout the procedure.

• 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: 7022839
• MDR Text Key: 92878255
• Report Number: 1722028-2017-00442
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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: 11/10/2017

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: 09/01/2018
• Device Catalogue Number: 10310
• Device Lot Number: 09Z3101
• Other Device ID Number: 05020583103108
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• 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: 00047 YR
• Patient Weight: 75