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

Catalog Number 10310

Device Problems Coagulation in Device or Device Ingredient (1096); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used optia idl set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Visual inspection revealed a small amount of product in the collect bag and no product in the plasma bag.The product collected in the collection bag was mostly clear with a pink tint.The tubing lines leading to the collect bag contained clear fluid with red blood cell (rbc) sedimentation.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a continuous mono nuclear cell (cmnc) collection on aspectra optia device the collected plasma was pink tinged.It was reported that about 5 minutes into the procedure, blood was in the return line, the operator had to repeat the venipuncture on the patient.The operator lowered the anticoagulant (ac) ratio from 11 to 8.The customer reported that there was a clotting issue in the inlet needle.The patient was disconnected and the procedure was restarted on a new disposable set and different machine without any issues of hemolysis.Per the customer the patient is in stable condition.Patient identifier, age, and weight are not available at this time.

Manufacturer Narrative

This report is being filed to provide in investigation: the customer provided a picture to tbct to aid in the investigation.Thepicture confirmed that the plasma collected into the collection bag was slightly tinged withpink, which is consistent with low level hemolysis.Updated investgiation: an optia idl disposable set was returned to terumo bct forinvestigation.It was noted that blood had circulated throughout the set.Visual inspectionrevealed a small amount of product in the collect bag and no product in the plasma bag.Theproduct collected in the collection bag was mostly clear with a pink tint.The tubing linesleading to the collect bag contained clear fluid with rbc sedimentation.Clots were observed in the inlet line filter confirming the customer's observation of clotting inthe inlet needle.Samples were extracted from the channel and reservoir for testing (thecollected plasma was not returned).Both samples were processed via lop-0142 to obtain acomplete blood count (cbc).However, the channel sample was extremely clotted with a veryhigh hct, so a dilution was required to get the cbc within instrument range.It wasdetermined that plasma free hemoglobin (pfh) testing should not be performed on thechannel due to sample integrity and lack of volume.Lop-0035 and lop-0037 were executedto measure pfh on the reservoir.The results of all measurements are provided in table 1.Table 1 wbc rbc plt hct total hgb plasma hgb hemolysis(x10e3/ul) (xloe6/ul) (x10e3/ul) (%) (g/dl) (mg/dl) (%)channel 1.7 6.7 158 79.6 21.8 na nareservoir 0.60 0.43 95 4.7 1.5 129.92 8.25clotting in the channel sample could impact instrument measurements.Testing delays andconfirmed uncontrolled shipping conditions could also contribute to inaccurate measurementsand elevated plasma free hemoglobin measurements.No further testing was performed.Root cause: based on the customer's description and the evaluation of the returned set,the cause of hemolysis is a result of clotting in the disposable set resulting in excessive shearforce that led to the hemolysis of rbcs.A definitive root cause of the clotting could not bedetermined.Possible causes include, but are not limited to:- inadequate anticoagulation of the extracorporeal system- patient's physiology.

Manufacturer Narrative

This report is being filed to provide in investigation: a terumo bct service technician checked out the device at the customer siteand verified operation of the device with a successful autotest and fluid run.The functional checkand semi annual preventive maintenance were completed per manufactures specifications.Investigation is in process.A follow-up report will be provided.

Event Description

After multiple attempts, the customer did not provide patient information or additionalprocedural details for this event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8807731
• MDR Text Key: 151877467
• Report Number: 1722028-2019-00193
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• 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: 07/19/2019

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: 12/01/2020
• Device Catalogue Number: 10310
• Device Lot Number: 1812193330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 07/31/2019; 08/19/2019
• Supplement Dates FDA Received: 08/13/2019; 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other