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

Catalog Number 000000000000010220

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

Patient Problems Itching Sensation (1943); Rash (2033); Reaction (2414)

Event Date 11/24/2014

Event Type  Injury  

Event Description

The customer reported that a patient had a reaction during a therapeutic plasma exchange(tpe) procedure.During the 7th return cycle of the procedure, the patient was given the last unit of fresh frozen plasma (ffp).The patient developed rashes on her back and legs and began to complain of itchiness.Per physician's order, 50 mg benadryl iv was administered to the patient.The patient, who was already hospitalized, did not require further follow-up and is reported in stable condition.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 50 mg benadryl iv.

Manufacturer Narrative

Investigation: fluids used during the tpe procedure: ffp 1893 mls, 1.0 total plasma volume.50% albumin and 50% ffp.Total replacement volume4179 ml.This patient also went through a 2nd tpe procedure two days later and showed rash again at the end of that procedure.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.The run data file (rdf) was analyzed for this event.Based on the run data file analysis, the spectra optia system operated as intended.There is no indication of what may have caused the patient to have developed a rash following the procedure.A service call was placed for the equipment.Terumo bct service technician verified all pump occlusions and fluid detectors were functioning per manufactures specifications.An auto test and saline run were performed with no issues found.Root cause: this disposable set was unavailable for specific root cause analysis.The rdf was analyzed and a service call was placed for the machine.A definitive root cause for the reaction could not be determined.Based on customer statements and the same patient having a rash on a procedure two days later, it is likely that the patient response is related to a transfusion reaction to fresh frozen plasma.The spectra optia apheresis system essentials guide offers the following warnings and cautions:-"when using biologically-derived replacement fluids, closely monitor the patient for reactions."-"the spectra optia system has many safety features.However, a patient reaction can occur rapidly.Therefore, it is imperative that the operator monitor the patient and the system throughout the procedure."-"be aware of possible patient reactions to apheresis procedures, and be prepared to take appropriate action should any reactions occur.Some previously reported reactions are:¿ anxiety¿ headache¿ light-headedness¿ digit and/or facial paresthesia¿ fever¿ chills¿ hematoma¿ hyperventilation¿ nausea and vomiting¿ syncope (fainting)¿ urticaria¿ hypotension¿ allergic reactions".

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 on the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4346393
• MDR Text Key: 5216545
• Report Number: 1722028-2014-00494
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK130065
• 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
• Report Date: 11/24/2014

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: 07/01/2016
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 07W3329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/09/2015; 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2014
• 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): Required Intervention
• Patient Age: 00046 YR
• Patient Weight: 109