MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA RBCX SET

Catalog Number 000000000000070700

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pallor (2468); Cognitive Changes (2551)

Event Date 12/12/2014

Event Type  Injury  

Event Description

The customer reported that an hour into a therapeutic plasma exchange (tpe) procedure, a patient became pale, hypotensive, and exhibited a change in level of consciousness.It was then that the customer realized that they had loaded and used a red blood cell exchange(rbcx) disposable set instead of a tpe set for the procedure.They had been collecting red cells instead of plasma and replacing with albumin.The procedure was ended and the contents of the remove bag (2700ml rbcs and anti-coagulant) were returned to the patient.A unit of packed rbcs were also given to the patient, per doctor's order.The patient continued in the intensive care unit (icu) after the event and is stable and improving.The customer declined to provide patient identifier and age.The disposable set was disposed of and is not available for return.This report is being filed due to medical intervention via a unit of packed red blood cells given to patient in response to the event, and due to device malfunction in the form of operator error.

Manufacturer Narrative

Investigation: per the customer, the procedure was being performed in a dark room, and the customer was not able to see that red cells were being removed instead of plasma.At the time the procedure was stopped, the patient had received 2370ml of albumin replacement fluid.The customer provided a photo of the set that had been used, and terumo bct was able to confirm that the set was a rbcx set.Per the customer, they are putting measures into practice to ensure the same error does not occur again.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: given the information provided by the customer, the root cause is an incorrect set was loaded and used for a procedure.The error was not realized until an hour into the procedure because it was being performed in a dark room which prevented the operator from being able to easily identify the fluid going to the waste bag.

Manufacturer Narrative

Corrective and preventive action: an internal capa has been initiated to address user interface issue of using an incorrect disposable set for a procedure.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury of the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA RBCX SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4389839
• MDR Text Key: 20754547
• Report Number: 1722028-2015-00004
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831004B
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2014

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?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 000000000000070700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 01/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2016
• 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): Required Intervention
• Patient Weight: 57