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

Model Number 12320

Device Problems Misassembled (1398); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a misassembled optia set, they stated that the saline roller clamp was on the return blood tubing.They received a high return pressure alarm and rinseback was not possible.Patient outcome is not available at this time.Patient id, age and gender are not available at this time.Terumo bct is awaiting return of the disposable set.

Event Description

Per the customer, "according to the optia protocol, 47 ml of saline was drained plus what was left in the set.We can no longer determine this more precisely.But about 900ml were still in the bag." customer estimated only 100ml unintended saline bolus was sent to the patient.Pursuant to eu personal data protection laws, the patient identifier is not available from the customer.No clinical or technical 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, b.5, b.6, e.1, h6 and h10.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 fluid balance was determined to be within fluid balance limits.The run data file (rdf) was analyzed for this event.According to the rdf, the final configured fb was 100% and the patient's tbv was 4120ml.The unintended saline bolus was approximately 100ml.Final fluid balance with saline bolus: [(4120ml + 100ml)/4120ml]*100 = 102.4%.This fluid balance is 2.4% higher than reported by the device and is within the intended fluid balance limits for the procedure.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.Review of the disposable set confirmed that the return saline roller clamp was misassembled onto the return line instead of the return saline line which was the root cause for the issues experienced in this procedure.Review of the dlog corroborates this finding with the occurrence of the ¿return saline line failed integrity test¿ during the disposables test and the numerous ¿return pressure was too high¿ alarms from the start of the procedure.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.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposables history search confirmed there were no similar occurrences reported on this lot worldwide.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.The manufacturing error also allowed return contents to flow up the return saline path instead of to the patient resulting in a small blood loss in this case.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.Correction: terumo bct has implemented a correction for this incident.Manufacturing staff were made aware of this issue and retrained to the appropriate procedures.

Manufacturer Narrative

This report is being filed to provide additional information in d.9, h.3 and h.10.Investigation: one optia idl disposable tubing set containing blood product was received for investigation.Initial observations noted that the ac and saline drip chambers had been rf sealed and removed prior to return.The saline bag was not returned for measurement.Visual examination of the returned component confirmed that the return saline roller clamp had been incorrectly assembled onto the clear return tubing, a yellow hemostat was clamped onto the green return saline tubing.Fluid was observed along the length of the saline tubing.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11194398
• MDR Text Key: 228693793
• Report Number: 1722028-2021-00019
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2007153330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00058 YR
• Patient Weight: 68