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

Catalog Number 10220

Device Problems Device Displays Incorrect Message (2591); Misassembly by Users (3133)

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

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The signals in the run datafile indicate that the spectra optia system operated as intended by triggering the reservoir alarms.The reservoir alarms were resolved after the operator closed the clamp on the inlet saline line.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately 20 minutes into a therapeutic plasma exchange(tpe) procedure, they received multiple alarms including 'low level reservoir sensor detected excess fluid' alarm.The customer contacted (b)(6) for troubleshooting.The (b)(6) had her stop the centrifuge and check loading of the disposable set.No obstructions were observed in the lines.The customer discovered that she had left the roller clamp on the access saline line open.She closed the access saline roller clamp and pinch clamps on the return line.It is not known at this time if medical intervention was required for this event.Patient identifier and age are not available at this time.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

Additional evaluation method code: mechanical evaluation investigation: the disposable set was unavailable for return and investigation.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the saline roller clamp being left open by the operator.A service call was performed on the machine.No issues were found with the equipment check and an auto test and saline run was successfully performed.Root cause: the signals in the rdf indicate that the spectra optia system operated as intended.Based on the rdf and the customer's statements, the root cause for the alarms was due to the operator leaving the access saline line clamp open.

Event Description

The customer did not respond to attempts to obtain information for the investigation such as, procedural details, patient identifier and age, initial reporter's occupation, and follow-up.

Manufacturer Narrative

This report is being filed to provide additional information.

Event Description

The customer stated that the patient is in stable condition and the patient was already hospitalized when the event occurred.No medical intervention was necessary for this event and no additional follow-up visit was required.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 5191544
• MDR Text Key: 30424563
• Report Number: 1722028-2015-00599
• Device Sequence Number: 1
• Product Code: LKN
• 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,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 10220
• Device Lot Number: 07Y3129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2015
• 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: 00056 YR
• Patient Weight: 80