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

Catalog Number 10220

Device Problems Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591); Misassembly by Users (3133)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: the signals in the run data file indicate that the spectra optia system operated as intended.The spectra optia system is designed to monitor the fluid pumped into the remove bag as well as the amount of fluid returning to the reservoir.The upper and lower reservoir sensors are designed to identify unexpected fluid in the reservoir.Signals in the run data file indicates that the patient fluid balance alarms were triggered when the system detected a discrepancy in the amount of fluid that was expected in the reservoir.This is commonly caused by an obstruction in the remove line below the waste bag or below the cassette in the centrifuge or the plasma line in the centrifuge.Following the final ¿patient¿s fluid balance may be 15% higher than reported¿ alarm, the system forced the operator to discontinue the procedure in order to protect the patient¿s fluid balance.After unloading the set, the operator found the inlet saline roller clamp had been left partially open, which would affect the amount of fluid going to the reservoir and was the likely cause of the fluid balance alarms that were triggered during this run.The disposable set contained with blood was returned for investigation.Upon visual inspection, it was noted that upon receipt of the set both the inlet saline line roller clamp (red) and the return saline line roller clamp (blue) were partially closed.Also, the remove tubing line going from the cassette to the remove bag was not sealed/clamped off prior to shipment which allowed fluid to free flow back into the disposable system during return shipping of the set.The following volumes were measured by cutting the tubes/bags and allowing the fluid to drain into a graduated cylinder.Two thousand one hundred sixty six ml waste/remove bag 98ml cassette including reservoir 30ml loop and channel assembly 2294ml total volume in set the remainder of the set was visually inspected for kinks, occlusions, missing parts and misassemblies and none were found.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately 45 minutes into a red blood cell exchange (rbcx)procedure, they received multiple alarms including 'patient's fluid balance may be 15% lower than reported' alarm that caused them to end the procedure.While the operator was disconnecting the patient and unloading the disposable set, he noticed that the inlet saline roller clamp had been left partially open.A new disposable set was setup on a different machine and the procedure was successfully completed.No medical intervention was necessary for this event.The patient is reported in stable condition.The customer declined to provide the patient identifier and age.

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.Root cause: based on customer's statements about the set when unloading and the rdf analysis, the root cause for the fluid balance alarms is due to user interface in not closing the saline clamp when prompted.The customer declined additional training or follow-up regarding this incident.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5057669
• MDR Text Key: 25233429
• Report Number: 1722028-2015-00512
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• 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: 07Y3216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 67