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

Catalog Number 12220

Device Problems Particulates (1451); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during multiple spectra optia exchange procedures, they observed aggregates in the return chamber.The customer stated that in some cases the ac ratio was adjusted to 1:10 without calcium to complete the procedures.Per the customer, one patient successfully completed 4 exchange procedures, however,aggregates were noted during the 5th exchange procedure.Specific dates of the events and specific patient information is not available at this time.It is not known at this time if medical intervention was necessary for any of the events.The spectra optia exchange sets are not available for return because they were discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: during customer follow-up, the customer indicated that the patient reacts strongly to the extra fluid volume during the treatment and therefore has historically taken drugs for dehydration for a few days following the treatment.Therefore, this is not considered medical intervention as it has been done historically for this patient and the drugs for dehydration was pre-prescribed.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to: the inlet/anti-coagulant ratios used in the procedure were inadequate to keep the extracorporeal circuit properly anti-coagulated, resulting in the activation of platelets;.Activation of platelets because of the patient's physiology.

Manufacturer Narrative

This report is being filed to provide additional information.And corrected information.Investigation: the customer stated that the spectra optia exchange procedure that began approximately at 8 am, was performed in semi-automatic mode.Further clarification was also received from the customer that the reported multiple incidents from (b)(6) 2017 occurred on the same patient.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.The customer confirmed that the aggregates were not returned to the patient/donor and aggregates were only observed in the return reservoir.Therefore, the aggregate was at a point in the disposable set where it could not be returned to the patient/donor.Investigation is in process.A follow-up report will be provided.

Event Description

Further clarification was received from the customer in regards to the reported incident.The customer stated that the spectra optia exchange procedure began approximately at 8 am.During the procedure, they observed aggregates in the return reservoir, therefore, the operator adjusted the anti-coagulant (ac) ratio to 1:10 for approximately 10 minutes without calcium.As the operator still observed aggregates in the return reservoir, the operator made another adjustment to the ac ratio to 1:10.While the operator still observed aggregates, the ac ratio was lastly adjusted to 1:25.The cardiologic patient reacted strongly to the intravascular volume, therefore, the patient was monitored till the end of the procedure.Due to eu personal data protection laws, the patient identifier, age, weight, and outcome are not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per the customer, multiple incidents occurred on (b)(6) 2017 from 8:15am to 20:20pm, however, it is unknown at this time if multiple patients were involved.A run data file (rdf) from (b)(6) 2017 was analyzed for this event.Review of the rdf and interface images associated with this complaint confirmed the presence of clumping in the connector for the entirety of the spd procedure.The likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.The clumping persisted for the duration of the run.Information from the customers specifies that the inlet:ac ratio was set at 25 in order to manage the fluid balance.The total volume of the ac used during a tpe-spd procedure is returned to the patient with the treated plasma.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.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.

• 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: 6682978
• MDR Text Key: 79134747
• Report Number: 1722028-2017-00274
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 12220
• Device Lot Number: 02A3208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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: 108