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

Model Number 12320

Device Problems Misassembled (1398); Increase in Pressure (1491)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation : one used optia set was received for investigation.Initial observations noted the ac bag was rf sealed and removed prior to return.The saline bag was rf sealed and detached but was returned with the set.There was approx.225ml of saline in the bottle and the drip chamber was approx.10% full.The collection bags were also rf sealed, detached but returned with the set.Visual inspection noted blood throughout the set with clumping in the inlet pressure sensor, inlet line trap, channel and in the connector.The blue return saline line roller clamp was noted to be assembled on the incorrect line.It was on the clear return line instead of on the green saline return line, and was in the closed position.The red inlet saline line clamp was assembled on the correct line and was in the closed position.Further inspection noted no kinks, missing parts or any further misassemblies.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during priming, they closed the roller clamp.They received a 'return pressure too high' alarm.The operator did air removal then closed the roller clamp.When the roller clamp was closed, the return pressure value rose above 400.The roller clamp was opened and the pressure returned to normal.Per the customer, the whole process worked in reverse.The patient's return vein was in order, the return tube was in order, and the flow rate was not high.Patient information and outcome are not available at this time.

Event Description

Pursuant to eu personal data protection laws, the patient identifier is not available from the customer.Additionally, this unit was transfused, and no patient reaction was reported.No clinical issues were reported at the time of the reported incident.

Manufacturer Narrative

This report is being filed to provide additional information in a.2, a.3, a.4, b.5, b.6, e.1, h.6 and h.10.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.The patient's fluid balance was determined to be within acceptable limits.The run data file was analyzed for this event.The system operated as intended by flagging during the pressure test with the ¿return saline line failed integrity test¿ alarm, which was generated due to the misassembled roller clamp.According to the rdf, the final fluid balance reported by the system was 99% and the patient's tbv was 3784ml.The unintended saline bolus was approximately 275ml.Final fluid balance (as reported by the system 3732ml) with saline bolus: [(3732ml + 275ml)/ 3784ml] 100 = 106%.The device history record (dhr)was reviewed for this lot.There were no issues noted in the dhr that would have contributed to this event.Correction: terumo bct manufacturing staff were retrained to the appropriate procedures.Root cause: the root cause for an unintended saline bolus to the patient was due to the disposable set being manufactured without the return roller clamp on the return saline line.If this line is not clamped, saline can gravity drain freely through the return line to the patient, which can lead to a risk of hypervolemia.A definitive root cause for the roller clamp being installed on an incorrect line relates to a manufacturing mis-assembly where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11516099
• MDR Text Key: 244844937
• Report Number: 1722028-2021-00115
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2010213130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00066 YR
• Patient Weight: 65