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

Catalog Number 70600

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Chills (2191); Reaction (2414); Shaking/Tremors (2515)

Event Date 06/06/2015

Event Type  Injury  

Manufacturer Narrative

Investigation: the inlet ac ratio for the procedure was 1:14.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that 75 minutes into a stem cell collection procedure, the patient experienced a reaction.They had chills with rigors, vomiting, hypotension and fever.It is unknown if medical intervention was required for this event.Patient information is unavailable at this time.Patient outcome is unavailable at this time.Terumo bct is awaiting return of the disposable set for evaluation.

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.The disposable kit was requested but was not available for further analysis.The customer stated that they performed an internal investigation but could not determine the cause of the reaction.The customer has begun to use cobe spectra again without any adverse events.The on-site physician stated that the adverse event was not caused by the equipment or disposable kit.Per the cobe spectra essentials guide, the cobe spectra system has many safety features.A 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: although a definitive cause for the adverse reaction could not be determined, the customer¿s internal review concluded that the equipment and disposable kit were not defective.It is possible that the patients¿ physiology caused the reaction.

Event Description

The patient's condition did not deteriorate further after the procedure and no further care for the symptoms was required.The customer declined to provide patient information.

• 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: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5072156
• MDR Text Key: 25614558
• Report Number: 1722028-2015-00538
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 08/19/2015

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: 08/01/2016
• Device Catalogue Number: 70600
• Device Lot Number: 08W15248
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2016; 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2014
• 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): Other