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

Catalog Number 000000000000070500

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 03/04/2015

Event Type  malfunction  

Event Description

The customer reported that they inadvertently used a cobe spectra therapeutic plasma exchange (tpe) disposable set for a red blood cell exchange (rbcx) procedure.Approximately 53 minutes into the procedure, the operator noticed plasma in the waste bag instead of red blood cells.The operator aborted the procedure.Per physician assistance's order, post complete blood count (cbc) was performed.A rbcx disposable set was setup on the same machine and the procedure was successfully completed.The patient is reported in stable condition.The customer declined to provide patient's identifier.The disposable set is not available for return because the customer discarded it.

Manufacturer Narrative

Investigation: fluids used were 0.9% normal saline and rbcs.Volume removed from the patient was 842 ml and volume received was 1155 mls.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.All spectra procedures use a confirmatory screen at the beginning of prime that states what disposable was entered.During run, the procedure type is displayed in the corner of the screen.Also, the data entry screens are different for each type of procedure, making mistakes more obvious.Root cause: the root cause for the increased patient hct post procedure was due to the operator loading a spectra tpe set instead of a spectra rbcx set for an rbcx procedure.Additional information: complaint data for this customer was reviewed and there were no other similar incidents involving user interface, therefore no customer retraining is necessary at time.

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

Investigation: through discussion and follow up, the customer is aware that the increased patient hct was due to the operator loading a spectra tpe set when an rbcx should have been loaded.The customer also stated that they were implementing disciplinary action at their site.

Event Description

No medical intervention was required for this event.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE 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: 4639091
• MDR Text Key: 19603943
• Report Number: 1722028-2015-00118
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2015

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: 10/01/2017
• Device Catalogue Number: 000000000000070500
• Device Lot Number: 10W15237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 03/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/21/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• 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: 00033 YR
• Patient Weight: 58