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

Catalog Number 000000000000010220

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); Death (1802); Dyspnea (1816); Sore Throat (2396); Low Oxygen Saturation (2477)

Event Date 05/30/2014

Event Type  Death  

Event Description

The customer reported that a patient in icu was undergoing a therapeutic plasma exchange(tpe) procedure in tandem with continuous veno-venous hemofiltration (cvvh).Approximately 15 minutes prior to completion of the tpe procedure, the patient was coughing,complained that his throat was hurting and felt short of breath.The patient's heart rate ando2 saturation decreased.The icu nurse called a code and attempted intubation.The patient then expired after the code was called.The disposable set was not available for return for evaluation because it was discarded by the customer.This report is being filed due to patient death, though at this time it is not suspected or alleged that the device was a contributory factor.

Manufacturer Narrative

Investigation: per the customer, the patient had been treated in (b)(6) at a sister facility wherehe was admitted and had 5 tpe procedures in tandem with cvvh.He had been intubated at thattime.He was septic with loss of consciousness changes, multiple system organ failure, respiratoryproblems and stroke.He was sent to the current facility for rehab.He was on o2 by cannula,breathing on his own, alert, and talking with his brother during the procedure.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed.The signals in the run data file indicate that the spectra optia system operated as intended.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.A service call was placed and a full machine checkout was performed.The machine is functioning per manufacturers specification.A review of the lot for similar reports was carried out and none have been reported.Multiple attempts to gather further information regarding the procedure and autopsy results remain unanswered.Root cause: this disposable set was unavailable for specific root cause analysis.The rdf and the service call show that the system operated as intended.A definitive root cause could not be determined.Based on the statements from the customer, possible causes include but are not limited to compromised patient physiology or related to how the cvvh procedure interacted with the apheresis procedure.Spectra optia apheresis system essentials guide offers the following procedural caution: "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.".

Manufacturer Narrative

Additional information: the medical director stated that the patient death was due to pulmonary embolus.

Manufacturer Narrative

Additional information: according to "therapeutic apheresis: a physician's handbook," the rate of adverse events during therapeutic apheresis is 4%-5%.Morbidity and mortality related to therapeutic procedures are greater in acutely ill patients treated in a hospital setting.A patient's death during an apheresis series is most often attributed to the underlying disease and is rarely directly related to the procedure.Root cause continued: the evidence from this investigation indicates that the device did not cause or contribute to the patient death.Literature review also indicates that a patient's death during anapheresis series is most often attributed to the underlying disease and is rarely directly related to the procedure.Based on the statements from the customer, the patient was septic and medically compromised with multi-system organ failure, respiratory problems, and stroke.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information to align with the reported event.

• 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: 3900226
• MDR Text Key: 4650237
• Report Number: 1722028-2014-00252
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK130065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 02W3225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CVVH 05/30/2014
• Patient Age: 00017 YR
• Patient Weight: 177