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

Catalog Number 10220

Device Problems Misassembled (1398); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, 7340 ml was processed for plasmapheresis and plasma exchange of 3000 ml.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a mis-assembly of the roller clamp on a therapeutic plasma exchange set.The roller clamp from the saline return line was placed on the return line tubing.Per the customer, the customer used their own clamp to stop the flow of saline.No medical intervention was required for this event.The therapeutic plasma exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Based on the patient's tbv and assuming worst case scenario of the entire contents of the saline bag being returned to the patient, the investigator determined that the fluid balance would be 118%.Upon photographic inspection, it was determined that the roller saline clamp is misassembled on the return line.The picture also shows that a hemostat was applied to the saline line by the customer.It is unclear from the customer when this missassembly was noticed and when the hemostat was placed on the saline line.This indicates that saline was allowed to free flow to the patient until the customer obstructed the flow with the hemostat.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Rdf analysis showed the ¿return saline line failed integrity test¿ alarm was generated four times during the disposable set test.This alarm is generated when the pressure at the return pressure sensor exceeds 100mmhg.During disposable set test, the pinch clamp on the return line should be open and the roller clamp on the return saline line should be closed.Consequently, the most common cause of this alarm is when one of these clamping configurations is incorrect.In this case, the roller clamp was found to be on the return line instead of the return saline line.When the system prompted the operator to close the return roller clamp, the misassembly resulted in closure of the return line, not the return saline line, and triggered the alarm.Immediately after the procedure was started, numerous ¿return pressure was too high¿ alarms were generated.After prime and prior to the start of the run, the spectra optia machine instructs the operator to close all clamps.As such, the most likely cause of the return pressure alarms at the onset of the procedure is again the closed roller clamp on the incorrect line.The return pressure alarms persisted for approximately 18 minutes.Based on these events, saline may have been free flowing to the patient for approximately 18minutes.The tbv of this patient is 5304ml.In order to exceed 20% of the patients tbv,1060ml of saline would have to be delivered to the patient during this time.Typical saline bags come in 500ml or 1000ml volumes.Given that the operator noticed the error and stopped the flow of saline early in the run, it is not believed that the hypervolemia limit for this patient was exceeded.Root cause: based on the rdf analysis and the part evaluation, the root cause for the alarms is due to the return saline roller clamp being misassembled on the clear return line instead of the green saline line.It is likely that the alarms resolved when the operator noticed the misassembly and used a hemostat to occlude the saline line to proceed with the procedure.The root cause for the roller clamp misassembly is due to the assembler not following the appropriate manufacturing operating procedure of the disposable set during manufacturing.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6538087
• MDR Text Key: 74366355
• Report Number: 1722028-2017-00162
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• 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: 10220
• Device Lot Number: 07Z3314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• 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: 00076 YR
• Patient Weight: 87