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

Catalog Number 70620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Septic Shock (2068); Chills (2191)

Event Date 09/20/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that during a stem cell collection procedure, the patient developed a fever and chills.He was transported to the emergency room and later was admitted to the icu and was given unknown medications.Approximately 15 hours after he was admitted to the icu, he developed septic shock symptoms.Per the customer, granulokine (filgrastim) was administered to the patient prior to the collection procedure.Patient information is not available at this time.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a bacterial culture was taken from the patient and test results were negative.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per the therapeutic apheresis handbook: a physician's reference, 2nd edition, first time procedure patients reactions may occur in approximately 4.8% of procedures, and 1.2% of procedure patients experience reactions to citrate, based on the results of a survey of therapeutic procedures.Of these reactions, most were mild and well tolerated.The cobe spectra system has many safety features.A donor and/or patient reaction can occur rapidly, however.It is imperative that the operator continuously monitor the cobe spectra system and the donor and/or patient.Root cause: this disposable set was unavailable for specific root cause analysis.Based on information provided by the customer, it is possible that patient exhibited a reaction to acd-a and/or eto.

Event Description

The customer did not respond to attempts to obtain information for the investigation such as, procedural details and patient information.

• 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: jessica kim ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 5159999
• MDR Text Key: 28674274
• Report Number: 1722028-2015-00591
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Followup
• Report Date: 09/24/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 70620
• Device Lot Number: 03Y15217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• 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): Hospitalization; Other