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

Catalog Number 70500

Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate User Interface (2958)

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

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

Lot number, expiry and manufacture date are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer contacted terumo bct's support line during a mononuclear cell (mnc) collection procedure on a patient.Approximately an hour into the procedure, they had difficulties in establishing an interface.The support specialist had the operator check the disposable set loading and saline roller clamps.The operator discovered that she had left the access saline roller clamp open and the saline was diverting toward the patient.She immediately closed the access saline roller clamp and an interface was established.The procedure was continued and successfully completed.No medical intervention was required for this event.The patient is reported in stable condition.Per the customer, the patient did 'well' and was discharged home post collection procedure.The customer declined to provide patient identifier (id) and age.The mnc collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Terumo bct's support specialist performed a calculation on patient's fluid balance from the value's provided by the customer and determined that the fluid balance was 119%.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.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Root cause: root cause of this incident was determined to be due to an operator error, wherethe operator inadvertently left the saline roller clamp open, allowing saline to flow to the patient.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6450735
• MDR Text Key: 71696267
• Report Number: 1722028-2017-00104
• Device Sequence Number: 1
• Product Code: GKT
• 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,Followup
• Report Date: 03/31/2017

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: 70500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/31/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/19/2017; 05/12/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70