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

Catalog Number 10220

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation: the customer stated they believed this event happened due to the high position of the blood warmer in relation to the patient.The customer sent pictures of the set to a terumo bct technician for evaluation.The procedure had been almost completed when the pictures were taken.What the technician found in the pictures was consistent with outgassing from warming the replacement fluid and returning blood to the patient.Device lot # is not known at this time.Investigation is in progress.A follow-up report will be provided.

Event Description

The customer reported observing tiny bubbles in the return line during a therapeutic plasma exchange (tpe) procedure.Bubbles were seen in the blood warmer tubing and at a certain point in the procedure the bubbles moved towards the patient.Further details regarding the procedure are not known at this time.The customer reported there was no injury and the patient is in stable condition.The customer declined to provide the patient identifier.The disposable set is not available for return, because it was discarded by the customer.

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.The run data file (rdf) was analyzed for this event.Signals in the rdf indicated that the optia system operated as intended.Root cause: photographs provided of the return line tubing on the blood warmer show bubbles that are consistent with outgassing from warmed replacement fluid.Outgassing can occur when blood returned to the patient is warmed using a blood warmer and occurs because gasses are more soluble in low temperature liquids than in liquids at higher temperatures.Outgassing is sometimes seen when blood or replacement fluids are re-warmed by a blood warmer in exchange procedures.It is usually described as chains of very small bubbles or foam, which tend to rise toward the top of the tubing and may coalesce to form larger bubbles.Outgassing and risk of air infusion can be minimized by either warming the replacement fluids before use, or by positioning the blood warmer between the replacement fluids and the replacement line of the tubing sets.Feedback regarding outgassing was provided to the customer.

Manufacturer Narrative

Root cause: photographs provided of the return line tubing on the blood warmer shows bubbles that are potentially associated with outgassing from warmed replacement fluid.Outgassing can occur when blood returned to the patient is warmed using a blood warmer and occurs because gasses are more soluble in low temperature liquids than in liquids at higher temperatures.Outgassing is sometimes seen when blood or replacement fluids are re-warmed by a blood warmer in exchange procedures.It is usually described as chains of very small bubbles or foam, which tend to rise toward the top of the tubing and may coalesce to form larger bubbles.It is also possible that the bubbles are the result of a small luer leak at the blood warmer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5896526
• MDR Text Key: 53792099
• Report Number: 1722028-2016-00468
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 08/23/2016

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: 05/01/2018
• Device Catalogue Number: 10220
• Device Lot Number: 05Z3218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/14/2016; 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• 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 Age: 00066 YR
• Patient Weight: 51