MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA WHITE BLOOD CELL SET, CLOSED

Catalog Number 70620

Device Problems Device Expiration Issue (1216); Inadequate User Interface (2958)

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

Event Date 05/02/2017

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 reported that an expired set was used for a dendreon collection procedure.It is unknown at this time if the product collected was used.Patient outcome is not available at this time.Patient information is not available at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation is in process.A follow-up report will be provided.

Event Description

The patient is reported in stable condition.

Manufacturer Narrative

This report is being filed to provide corrected information.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: per information provided by the customer, the set was used on 5/2/2017 and the expiration date on the disposable set label was 5/1/2017.The spectra white blood cell disposable set sterilization is validated for 2 years and 2 months.Review of terumo bct's sterilization log indicates that the disposable set completed the sterilization cycle on 5/6/2015, excluding aeration, which means that the disposable set was used within the 2 year timeframe allotted timeframe.Terumo bct conservatively prints the 1st of each month as the expiration date, although this may be a shorter timeframe than the validated range.Based on this assessment, the kit is considered sterile and there is no risk to the patient.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the statement provided by the customer, the operator used a potentially expired disposable set, which suggest operator error.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: during customer follow-up, the customer stated that the collection set expired on 05/01/2017 and the set was used on (b)(6) 2017.Investigation is in process.A follow-up report will be provided.

Event Description

The customer declined to provide patient identifier.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA WHITE BLOOD CELL SET, CLOSED
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6593488
• MDR Text Key: 76191151
• Report Number: 1722028-2017-00192
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020041
• 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,Followup,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 70620
• Device Lot Number: 05Y15268
• Other Device ID Number: 05020583706200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2015
• 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: 77 YR
• Patient Weight: 118