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

Catalog Number 000000000000010220

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 07/25/2014

Event Type  malfunction  

Event Description

The customer reported that at the beginning of a therapeutic plasma exchange (tpe)procedure, they noticed the saline bag was empty.They discovered that they had left the saline line open and the patient had received approximately 300ml of saline.No medical intervention was required for this event.The customer declined to provide the patient identifier.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to a device malfunction in the form of operator error that has the potential for injury.

Manufacturer Narrative

Investigation: spectra optia machine reported a 100% fluid balance, +3mlat the end of the procedure, but didn¿t account for the extra saline at the start.It isn¿t clear either if the patient received all the saline, or some of it was part of the inlet volume.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 review of the lot for similar reports was carried out and none have been reported.Root cause: operational problem.Per feedback from the operator to clinical support, the operator confirmed not closing the inlet saline line roller clamp which contributed to this occurrence.

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.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: 4029504
• MDR Text Key: 21314049
• Report Number: 1722028-2014-00335
• 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
• Report Date: 07/25/2014

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: 04/01/2016
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 04W3208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 08/22/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/13/2014; 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2014
• 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
• Treatment: DIALYSIS
• Patient Outcome(s): Other
• Patient Age: 00037 YR
• Patient Weight: 56