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

Catalog Number 10120

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the collection set was analyzed.Visual examination confirmed that the inlet and return saline line roller clamps were present and located correctly.Upon receipt it was observed that the return saline clamp was closed, where as the inlet saline line clamp was open.Further examination observed the presence of rbc¿s in the return saline line.The clamp was visually inspected and no obvious manufacturing defects were found.Visual examination of the set confirmed the presence of platelet aggregates within the channel and chamber.Further platelet aggregation was observed in the return pump header tubing.The set was further examined for any kinks, leaks, occlusions, missing parts or other misassembly and none were found.The run data file (rdf) was analyzed.Per the customer, the saline bag was empty despite both saline line roller clamps being closed.Although the status of the roller clamps cannot be definitely confirmed from the rdf, the rdf indicates that the procedure had been paused in response to inlet pressure alarms during the procedure.If the customer had opened the inlet saline line roller clamp to help flush the inlet line of any obstructions and it were not closed when the procedure was resumed, an open inlet saline roller clamp would explain why the saline bag was empty when the procedure was ultimately ended.Therefore, the possibility of the inlet saline line roller clamp being left open after the system was paused cannot be ruled out.At the end of the run, the system reported the fluid balance of the patient to be 109% (i.E.332 ml positive).The customer indicated 500 ml of saline were in advertently delivered to the patient making the actual predicted fluid balance of the patient 832 ml positive.The patient¿s tbv is 3699 ml.Therefore, the estimated ending fluid balance of this patient given the described procedure events is 122%.

Event Description

The customer reported that following a mononuclear cell (mnc) collection procedure, they suspected their patient was +332 ml at the end of the procedure.In addition, they reported that 500 ml of saline were inadvertently delivered to the patient making the ending fluid balance of the patient 832 ml or 122%.Patient identifier and age are not available at this time.The patient outcome is unknown at this time.

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.Root cause: a definitive root cause was not determined related to the hypervolemia.Per the rdf analysis, it is possible that the saline clamp remained open for a duration during the procedure.

Event Description

Due to (b)(6) personal data protection laws, the patient information is not available from the customer.Patient's gender and weight were obtained from the run data file (rdf).

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6191641
• MDR Text Key: 63363329
• Report Number: 1722028-2016-00659
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Catalogue Number: 10120
• Device Lot Number: 07Z3101
• Other Device ID Number: 05020583101203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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): Other
• Patient Weight: 67