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

Catalog Number 10310

Device Problems Obstruction of Flow (2423); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf suggest an obstruction in the inlet line led to the alarms generated and subsequent review of the rdf associated with this complaint confirms the occurrence of excessive ¿inlet pressure was too low¿ alarms.Inlet pressure alarms and return pressure alarms started shortly after onset of the run and persisted for the duration.Later on during the procedure there were several ¿inlet pressure sensor malfunctioned¿, ¿low-level reservoir sensor did not detect fluid¿, and ¿patient's fluid balance may be 20% lower than reported¿ alarms.If the inlet line or inlet line trap develops an obstruction or partial occlusion from a skin plug or clot, this can cause the malfunction of the inlet pressure sensor and explain these alarms.In addition, a development of a clot in this location may cause the inlet line to stop drawing entirely, or to draw less fluid into the system because it is blocking the fluid pathway.This in turn can cause less fluid to exit the channel via the passive rbc line and can result in the reservoir alarms previously mentioned because less fluid is being returned to the reservoir than the system expects.Since these alarms occurred later in the procedure, it is suspected that clumps from the patient¿s access site were pulled into the inlet line later on during the run.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately 220 minutes into a continous mononuclear cell (cmnc) collection procedure, they received multiple alarms including, 'patient's fluid balance may be 20% lower than reported' alarm and noted an obstruction near the collect tubing line under the collection bag.The operator was unable to resolve the alarms and was left with the only option being to discontinue the procedure.A new disposable set was setup on the same machine on the following day and the procedure was successfully completed.No medical intervention was required for this event.Patient identifier and age are not available at this time.Patient's gender and weight were obtained from the run data file (rdf).The cmnc collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a service technician checked out the machine at the customer site and no anomalies were found.Investigation is in process.A follow-up report will be provided.

Event Description

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

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the customer stated that the patient had to be reconnected on the second day, however, they could not collect as expected since the patient was low in cd 34+ cells.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a definitive root cause for the fluid balance alarms could not be determined.Signals in the rdf suggest an obstruction in the inlet line led to the fluid balance alarms generated.Possible causes for this obstruction include but are not limited to clumps from the patient's access site pulled into the inlet line, other locations of clots or occlusion, and/or air block that obstructed flow.

• 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: 6767108
• MDR Text Key: 82064071
• Report Number: 1722028-2017-00312
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K153601
• 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: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: 10310
• Device Lot Number: 03A3217
• Other Device ID Number: 05020583103108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 08/14/2017; 09/22/2017
• Supplement Dates FDA Received: 08/29/2017; 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• 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 Weight: 50