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

Catalog Number 000000000000070620

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Urticaria (2278)

Event Date 08/05/2014

Event Type  Injury  

Event Description

The customer reported that a patient had an allergic reaction during a stem cell collection procedure.Approximately 90 minutes into the procedure, the patient developed massive symmetric urticaria on both hands, wrist joint, arm, ear, and groin.Per physician's order, intravenous 2 ampules fenistil, 1 ranitidin, and 100 mg prednisolon were administered to the patient via iv.The customer stated that the patient had obvious improvements after the medication.The patient stayed for observation in the clinic, then was fully recovered approximately an hour and a half later.Due to eu personal data protection laws, the patient information is not available from the customer.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to medical intervention in the form of intravenous 2 ampules fenistil, 1 ranitidin, and 100 mg prednisolon.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A review of the lot for similar reports was carried out, none have been reported.Per the customer, the patient did not have any previously known allergies.This was the patient¿s first collection procedure.No fluids were used other than acda during the procedure.Following the administering of the drugs and the period of rest for the patient, the procedure was restarted but ultimately ended early due to a clot in the inlet line.The apheresis product contained 3.4x10^6 cd34+ve cells/ kg bw.On (b)(6), the infusion of the cryopreserved autologous stem cells was performed without any allergic symptoms.According to the therapeutic apheresis: a physician¿s handbook, second edition, one of the most common complications seen during therapeutic procedures is urticaria, especially during the first procedure.Root cause: although a definitive root cause could not be determined, the symptoms of the patient¿s allergic reaction and the effectiveness of the medication prescribed make the root cause likely to be hypocalcaemia due to the acda.

Manufacturer Narrative

Per the cobe spectra apheresis system essentials guide, it provides the following cautions and suggestions to the operator with respect to a patient reaction: be aware of possible patient reactions during apheresis procedures.Previously reported reactions to apheresis procedures include urticaria, allergic reactions, among others.Be prepared to take appropriate action should any of these symptoms appear.Root cause: the root cause for the clot in the inlet line was possibly caused by, but not limited to, too low of an ac ratio and extended machine pause time.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, 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 of 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 ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4101589
• MDR Text Key: 17164568
• Report Number: 1722028-2014-00379
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2014

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: 08/01/2015
• Device Catalogue Number: 000000000000070620
• Device Lot Number: 08V15251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/07/2014; 12/19/2014; 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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): Required Intervention