MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA IDL SET, JAPAN

Catalog Number 10317

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

Lot number, expiry and manufacture date are not available at this time.Investigation: per the customer, the patient was very ill and it was difficult to identify the root cause of the event.The run data file (rdf) was analyzed for this event.Signals from the rdf showed that the device operated as intended.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during an apheresis procedure, a patient experienced a brain stem hemorrhage.It is unknown at this time if medical intervention was required for this event.Patient identifier, age, and outcome are not available at this time.Patient's gender and weight were obtained from the run data file (rdf).The spectra optia idl set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: based on the available evidence, the root cause for the brainstem hemorrhage was not related to the optia device.The doctor had scheduled a second wbcd for the(b)(6).Signals from the rdf analysis showed no alarms or abnormal procedure behavior.Given this information, the device was found to be operating as intended, and within the generally tolerated limits for a majority of patients.There was no system or device malfunction identified that may have contributed to the adverse reaction reported.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Additional investigation: according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Most complications and patient reactions during therapeutic apheresis procedures are considered minor and well tolerated.Updated root cause: based on the run data file (rdf) analysis, the root cause for the brainstem hemorrhage was not related to the optia device.Furthermore, the physician at the customer's site stated that the acd-a was unlikely related to the hemorrhage.The physician scheduled a second wbcd for (b)(6).The patient¿s hemorrhage is possibly related to the patient¿s disease state and/or patient¿s physiology.

Event Description

Due to (b)(4) privacy laws, the customer was unable to provide patient identifier and outcome.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET, JAPAN
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6788756
• MDR Text Key: 82508999
• Report Number: 1722028-2017-00322
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K153601
• 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,Followup,Followup,Followup
• Report Date: 08/11/2017

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: 02/01/2019
• Device Catalogue Number: 10317
• Device Lot Number: 02A3115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 09/01/2017; 10/27/2017; 01/15/2018; 02/12/2018
• Supplement Dates FDA Received: 09/05/2017; 11/10/2017; 01/19/2018; 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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
• Patient Age: 00012 YR
• Patient Weight: 40