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

Catalog Number 10300

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

Patient Problems Electrolyte Imbalance (2196); Reaction (2414)

Event Date 02/14/2012

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that a patient was undergoing a white blood cell depletion (wbcd) procedure.Approximately 2 hours post procedure, the patient experienced hypocalcaemia.Per physician¿s order, the patient was given calcium via iv.Patient information and outcome are not known at this time.The wbcd set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per terumo bct's clinical trial manager, the details provided for the investigation were gathered from the patient's medical record.Due to the study being closed, further access to the patient's medical record for follow-up cannot be obtained.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paraesthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to ac management during the procedure, patient disease state, and/or patient sensitivity to anticoagulant.

Event Description

Per physician¿s order, the patient was given 10% calcium via iv.

Manufacturer Narrative

Additional 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 service history for this device indicated that the device was actively service fora preventative maintenance (pm) in (b)(6) 2017 and no anomalies were noted.

Event Description

Due to eu personal data protection laws, the patient information is not available from thecustomer.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6526047
• MDR Text Key: 73893706
• Report Number: 1722028-2017-00157
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K103090
• 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
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2014
• Device Catalogue Number: 10300
• Device Lot Number: 01U3117
• Other Device ID Number: 05020583103009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2012
• 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