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

Catalog Number 12220

Device Problems Contamination (1120); No Apparent Adverse Event (3189)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

The customer reported that they received 'cells detected in plasma line in centrifuge' alarm for a therapeutic plasma exchange (tpe) procedure.The patient was on the machine for 10 minutes.The patient developed coughing and chest tightness when on the machine.The coughing and the chest tightness subsided about 15 min after taking off the machine.The alarm occurred about 8 or nine minutes into the run.There was fluid in the waste bag at this time.The plasma was orange tinged in the cassette.The procedure was discontinued per physician orders.No medical intervention was necessary.

Manufacturer Narrative

Investigation: a used optia set was returned for investigation.It was noted that blood warmer tubing was attached and returned with the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.All pressure sensors were inspected and determined to be functioning properly.Gravity was used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.The lower hex was inspected for evidence of loading.The latch pin witness mark of the lower hex was identified adjacent to the red inlet tubing indicting the lower hex was loaded in the centrifuge collar holder in a less than optimal position, which could cause a plasma line occlusion.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

Investigation: a used optia set was returned for investigation.It was noted that blood warmer tubing was attached and returned with the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.All pressure sensors were inspected and determined to be functioning properly.Gravity was used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.The lower hex was inspected for evidence of loading.The latch pin witness mark of the lower hex was identified adjacent to the red inlet tubing indicting the lower hex was loaded in the centrifuge collar holder in a less than optimal position, which could cause a plasma line occlusion.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.It was confirmed through lab testing that this event was an rbc spillover, not hemolysis.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported that they received 'cells detected in plasma line in centrifuge' alarm for a therapeutic plasma exchange (tpe) procedure.The patient was on the machine for 10 minutes.The patient developed coughing and chest tightness when on the machine.The coughing and the chest tightness subsided about 15 min after taking off the machine.The alarm occurred about 8 or nine minutes into the run.There was fluid in the waste bag at this time.The plasma was orange tinged in the cassette.The procedure was discontinued per physician orders.No medical intervention was necessary.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 15078743
• MDR Text Key: 296346305
• Report Number: 1722028-2022-00239
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2024
• Device Catalogue Number: 12220
• Device Lot Number: 2204013330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2022
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 80 KG