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

Catalog Number 10120

Device Problems Device Alarm System (1012); Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, a total of 1325ml of anti-coagulant (ac) was used.The acda bags were 500 mls each and they were on the 3rd bag when the issue occurred.Visually,there didn't appear to be 325mls missing from the 3rd bag.A bend in the ac line was also observed above the fluid sensor that was not noticed initially.The alarms did not occur until the end of the procedure.The product bag was manipulated after hanging the 3rd bag of acda and no problems were noted.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.Based on the information available in the rdf,the spectra optia system operated as intended.The signals in the rdf indicate that the ac fluid detector saw fluid in the ac line throughout the procedure.Based on the information available, it is possible but it cannot be confirmed that there was an underdelivery of acda to the circuit during this collection.The operator did observe a kink/bend in the ac line just above the ac fluid detector, however the disposable set was not available to be returned for investigation so there is no way to confirm if that kink/bend in the ac line could have been significant enough to restrict flow through the ac line.If there was an underdelivery of ac during the run, this could explain the clotting that was observed in the product bag, the collect line and the return line.It also cannot be ruled out that the inlet/ac ratio selected for this procedure could have been too high and lowering the inlet/ac ratio at the first indication of clumping in the channel or collect port could have helped prevent the clotting that was reported late in this procedure.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during an mononuclear cell (mnc) collection procedure, they received multiple return pressure alarms.The rn noticed platelet clumping in the collect line and small clots going back up to the saline bag.Per the rn, the inlet flow rate was decreased from 125ml/min to 90ml/min and confirmed that the patient's line was flushed and aspirated correctly.While she closed the stopcock to the patient and opened the saline line,she noticed there was no saline drip in the drip chamber.The procedure was aborted due to not being able to clear/resolve the alarms.The patient was disconnected from the procedure without rinseback.The customer stated that the patient is 'fine'.The customer declined to provide the patient identifier.The mnc 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 in evaluation codes and additional mfr narrative.Investigation: a service call was placed and a full machine check out was performed.The machine is functioning per manufacturer's specification.An auto test and saline run were successfully performed.Root cause: root cause of this incident could not be identified at this time.Based on the information available in the run data file, the spectra optia system operated as intended.The signals in the run data file indicate that the ac fluid detector saw fluid in the ac line throughout the procedure.Based on the information available, it is possible but it cannot be confirmed if there was an under delivery of acda to the circuit during this collection.The operator did observe a kink/bend in the ac line just above the ac fluid detector, however the disposable set was not available to be returned for investigation so there is no way to confirm if that kink/bend in the ac line could have been significant enough to restrict flow through the ac line.If there was an under-delivery of ac during the run this could explain the clotting that was observed in the product bag, the collect line and the return line.It also cannot be ruled out that the inlet/ac ratio selected for this procedure could have been too high and lowering the inlet/ac ratio at the first indication of clumping in the channel or collect port could have helped prevent the clotting that was reported late in this procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w. collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5939721
• MDR Text Key: 54790657
• Report Number: 1722028-2016-00516
• Device Sequence Number: 1
• Product Code: LKN
• 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: 09/09/2016

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: 03/01/2018
• Device Catalogue Number: 10120
• Device Lot Number: 03Z3309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2016
• 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: 00017 YR
• Patient Weight: 82