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

Catalog Number 10220

Device Problems Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

Lot number, expiry and manufacture date are not available at this time.During customer follow-up, the customer stated that on the following day, a tpe procedure was successfully completed without clotting issues.Per the customer, the dogs are hypercoaguable and the prednisone increased the clumping.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that clotting was observed approximately 2 hours into a therapeutic plasma exchange (tpe) procedure on a dog with immune mediated hemoltyic anemia.While a calcium gluconate infusion was given to the dog during the procedure, the operator observed clotting in the return line, inlet line, and connector.The operator stopped the procedure and disconnected the dog.The dog is reported in stable condition.The spectra optia exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the use of the spectra optia device on a dog is considered off-label use.The customer sent in a video of the procedure.A review of the video showed clumps moving past the white hub where the blood is being returned to the dog.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: a definitive root cause could not be determined.Based on the customer statements, possible causes for the clumps returning to the dog include but are not limited to:-customer using spectra optia on a dog which is considered off-label use-the calcium gluconate infusion during the procedure-the disease state or physiology of the dog (hypercoaguable)-use of additional medication during procedure (prednisone).

• 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: 6472178
• MDR Text Key: 72573836
• Report Number: 1722028-2017-00135
• 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: 04/07/2017

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 Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 00005 YR
• Patient Weight: 13