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

Catalog Number 70620

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Headache (1880); Arthralgia (2355); Shaking/Tremors (2515)

Event Date 09/15/2015

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, c-reactive proteins were normal, bacterial culture for donor and collected product had negative test results.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a granulocyte collection procedure, the donor developed a transitory fever, arthralgia, shakes, and headache.Post collection, the donor was transported to the emergency room (er) and was given dipyrone.The donor recovered and was released from the er the same day.The customer declined to provide patient (donor) information.The disposable kit is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per the customer, granulokine (filgrastim) and hydroxyethyl starch (hes) were administered to donor for this collection procedure.The cell collection was completed.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer did not respond to attempts to obtain information for the investigation such as, procedural details, patient information, and the serial number of the machine.Based on the information provided by the customer, the symptoms were likely due to the filgrastim (granulocyte stimulator) and hes that was administered to the donor for this collection procedure as well as contributions of hypocalcemia.The hrsa blood cell transplant "donation frequently asked questions" from the us department of health and human service indicates that side effects of filgrastim include headache, bone pain and muscle aches, which disappear shortly after donation.According to the therapeutic apheresis reference, hypocalcemia reactions from citrate include paresthesia (prickling or tingling), shivering, twitching, nausea and lightheadedness.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: the root cause for the donor reaction during the procedure cannot be determined.The symptoms experienced by the donor could be reactions to the following that were used and reportedly administered during the procedure.Filgrastim and hydroxyethyl starch can cause side effects such as headache, bone pain and muscle aches.Hypocalcemia reactions from the citrate used during apheresis can cause paresthesia, shivering, twitching, nausea and lightheadedness.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury in the mdr form.This supplement is being filed to modify information, per fda request.

• 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: 5144458
• MDR Text Key: 28039801
• Report Number: 1722028-2015-00581
• 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,Followup
• Report Date: 09/16/2015

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: 10/01/2016
• Device Catalogue Number: 70620
• Device Lot Number: 10W15225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2016; 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2014
• 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