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

Catalog Number 70600

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

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported after priming for a collection procedure, they noted air in the return line tubing.The operator unloaded and discarded the tubing set.Patient information and outcome are not available at this time.The tubing set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per information provided by the customer the set was not used after noticing the air in the return line.Additionally, the customer provided confirmation that no patient was connected to the system, prior to discarding the set.Photographs provided by the customer confirm that the set was not used.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a definitive root cause could not be determined.It is possible that the set was not fully primed, prior to ending the run and discarding the set.

Event Description

Per the customer, no donor was connected at the time of the event.No patient (donor)information is reasonably known.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA WHITE BLOOD CELL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6092743
• MDR Text Key: 60087294
• Report Number: 1722028-2016-00605
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: BK080035
• 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
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: 70600
• Device Lot Number: 01Z15275
• Other Device ID Number: 05020583706002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2016
• 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