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

Catalog Number 10220

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993); Pressure Problem (3012)

Patient Problem Death (1802)

Event Date 01/31/2017

Event Type  Death  

Manufacturer Narrative

Lot number, expiry and manufacture date are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer initially contacted terumo bct support specialist due to a patient that underwent several therapeutic plasma exchange (tpe) procedures.During the tpe procedures, they received multiple pressure alarms and had access issues due to the patient's catheter.When support specialist followed up with the customer on 02/21/2017, the customer informed her that the patient passed away.The customer stated that the patient withdrew care and chose comfort measures and the patient opted out for hemodialysis (hd) and tpe procedures.At this time it is not alleged or suspected that spectra optia exchange set caused or contributed to the patient death.Patient identifier (id) and age are not available at this time.The spectra optia exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the spectra optia machine was used for 5 therapeutic plasma exchange procedures and 1 red blood cell exchange (rbcx) procedure after (b)(6) 2017.The customer¿s contacted their biomed on (b)(6) 2017 due to several return pressure sensor alarms while the cassette was being loaded that the operator was unable to clear the alarms.The customer¿s biomed serviced the machine on (b)(6) 2017 for a "pressure sensor 1 failed zero range test" and "pressure sensor 1 failed post-load test" alarms.The pressure sensors were replaced.After two procedures were performed following the replacement of the return pressure sensor, they received the same return pressure sensor alarms.The customer¿s biomed contacted terumo bct for service call and machine checkout.Terumo bct¿s service technician performed a full machine checkout on (b)(6) 2017.The return pressure sensors were verified and were functioning properly per manufacturer¿s specification.The motherboard alignment was checked and confirmed that the motherboard was properly aligned, all connections were checked and tightened with no issues.The run data files (rdf) were analyzed from 1/31/2017, 02/01/2017, 02/02/2017, 02/03/2017,02/04/2017, 03/18/2017 and 03/20/2017.Based on the run data files (rdf) for analysis, the spectra optia system operated as intended.There is no indication that the frequent return pressure too high alarms are device related.Typically, when there is a sudden onset of pressure alarms during a procedure, it cannot be ruled out that this could have been due to patient movement that could have affected the flow to or from the access site.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

The physician at the customer's site determined that the patient expired due to vasculitis and pneumonia.Terumo bct's service technician performed a machine checkout on march 22, 2017.The e-box was verified for loose connections and wiring.The pressure sensors were also verified.The e-box and pressure sensors were functioning properly per manufacturer's specification.The service technician re-aligned the motherboard and replaced the pump rotor washers.An autotest and saline run was successfully performed and the machine is functioning per manufacturer's specification.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event,therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The physician declined to provide the patient's discharge report, however, the physician stated that the patient's death was due to their disease state and ultimately caused by vasculitis and pneumonia.Per terumo bct's medical review, the device did not cause or contribute to this incident.Root cause: the cause of the patient death as reported by the physician was vasculitis and pneumonia.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6412592
• MDR Text Key: 70182536
• Report Number: 1722028-2017-00081
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 00072 YR
• Patient Weight: 96