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

Catalog Number 10220

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 06/27/2016

Event Type  Injury  

Manufacturer Narrative

Investigation: a used optia set was returned for investigation.No defects were identified upon evaluation.The blood warmer tubing that was attached to the set showed some evidence of clumping, however it is not clear if these were present during the run.A review of the device history record for this lot showed no irregularities during manufacturing that would have contributed to the patient reaction as experienced by the customer.The machine involved in this event was evaluated at the customer site by terumo bct.No technical issues were found and the device was released for use.The run data file (rdf) was analyzed for this event.Review of the rdf does not indicate any issues or suspicious alarms during the procedure that may have contributed to the patient condition during rinseback.The procedure was stopped after the onset of rinseback and the patient was disconnected shortly after.There were no unusual alarms and the exchange procedure seemed to progress as expected.There were no signs of excess citrate given back to the patient or anything that may set off a patient reaction.No definitive root cause for the reported adverse event could be identified from the rdf associated with this procedure.The system operated as intended and the procedure was run within standard operating limits.According to therapeutic apheresis: a physicians' handbook 2nd edition, the rate of adverse events during therapeutic apheresis is 4% to 5%.Most complications are minor and well tolerated.Per the literature review, only 5 of the 1727 patients listed in the literature (0.3%)required discontinuation of therapy or transfer to a higher-acuity-care unit.Root cause: the rdf analysis of the procedure did not identify any potential sources of a patient reaction during the run.Along with the rdf analysis, the service check of the machine did not find any issues or causes related to the incident.The rdf analysis and service check indicates that the spectra optia device operated as intended and is safe to use.The part evaluation did not show any defects or issues with the set.Root cause for the patient reaction is inconclusive.Possible causes include but are not limited to the patient's disease state, a citrate reaction, and/or patient sensitivity to the procedure.

Event Description

The customer reported that they had begun the return cycle following and uneventful course of therapeutic plasma exchange (tpe).At the beginning of the return, the patient suffered brief bradycardia, followed by asystole that was immediately treated with cardiac massage.The rescue team was able to quickly restore the patient to a sufficient cardiac situation.The patient was transferred in stable condition to intensive care.Due to eu personal data protection laws, the patient information is not available from the customer.The patient's gender and weight were obtained from the run data file.

Manufacturer Narrative

After the patient was transferred to the intensive care unit, she showed no further problems.Oral calcium had been given before start of the procedure.This was the second of 5 procedures.Procedures 3, 4 and 5 were conducted without problems.

Manufacturer Narrative

Additional investigation: per terumo bct's medical review, the device did not cause or contribute to this incident.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5816251
• MDR Text Key: 50246146
• Report Number: 1722028-2016-00424
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K151368
• 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
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Catalogue Number: 10220
• Device Lot Number: 03Z3301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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): Hospitalization; Required Intervention
• Patient Weight: 42