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

Catalog Number 10220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Hemolysis (1886); No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that while three quarters of the way through the third therapeutic plasma exchange (tpe) procedure on the spectra optia machine, the operator noticed there were red blood cells (rbcs) in the waste bag.The operator increased the hematocrit (hct), but this did not help.The operator noticed the hemolysis in the waste bag after switching over to a mixed bag of albumin from the pharmacy.The operator notified the physician and received the ok to proceed with the run, but to discontinue the bag of albumin.Per the customer, the operator stated there was no separation or rbcs in the bottom of the waste bag, the color was still orange, so the physician was notified again and a decision was made to stop the run and disconnect the patient.The physician did not believe the hemolysis was due to the disease state of the patient.The patient id, weight and outcome 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

This report is being filed to provide inadvertently omitted date from initial report and additional information.Investigation: the device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the hemolysis as experienced by the customer.During subsequent follow-up with the customer, the operator confirmed that the system performed as intended by generating a cell detected in plasma line alarm, alerting him to address the conditions.Root cause: a definitive root cause could not be determined.Possible root causes include but are not limited to: hemolysis due to a full or partial occlusion in the disposable set; hemolysis due to pharmacy error in the premixed albumin.

Event Description

The customer declined to provide the id, weight, and status of the patient, however, per the customer, no medical intervention was necessary for this event.

Manufacturer Narrative

This report is being filed to provide corrected information.Completed investigation was not ready until 09/26/2018.

• 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: 7919267
• MDR Text Key: 123502030
• Report Number: 1722028-2018-00266
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Device Lot Number: 1806143230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2018
• 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: 75 YR