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

Catalog Number 10220

Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the plasma in connector is cherry dark color.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that 5 minutes into a red blood cell exchange (rbcx) on a thalassemia patient using a spectra optia device, they received an alarm 'aim system detected rbc interface near top of channel'.Per the customer, the interface was described as only pink plasma.Per terumo bct customer support, the customer was told not to press continue and the verify with the doctor at the customer site that the hemolysis was due to the patient's condition.The doctor ordered to disconnect the patient and the unit of blood was sent to the lab for hemolysis testing.It was reported that the doctor also ordered the following labs for the patient: ua, hemoglobin microscopic, ldh-hemolyzed, ast, ald, total protein, alk phos, total bili, electrolyte panel, calcium, albumin, creatinine, bun, cbc with diff, reticulocytes, ferritin and retic.Per the customer the lab results are pending and the patient is stable.Patient age is not available at this time.The customer declined to provide patient id.The disposable set is not available for return because it was discarded by the customer.

Event Description

After multiple follow-up attempts, the lab results and additional procedural details were not provided by the customer.

Manufacturer Narrative

Investigation: a disposable history search of the lot number found no other reports for this failure.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the cherry colored plasma as experienced by the customer.Root cause: a definitive root cause for the cherry colored plasma could not be determined.Possible causes include but are not limited to: - the patient's underlying disease state.- use of saline instead of ac, resulting in a hypotonic environment to the rbcs.- use of an incorrect saline concentration resulting in a hypotonic environment to the rbcs.- use of sterile water instead of saline resulting in a hypotonic environment to the rbcs.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and e.3.Investigation is in process.A follow up report will be provided.

Event Description

The customer declined to provide the patient's age.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9575384
• MDR Text Key: 177603764
• Report Number: 1722028-2020-00019
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: 10220
• Device Lot Number: 1909093330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 63