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

Model Number 10220

Device Problems No Audible Alarm (1019); Use of Device Problem (1670); Device Misassembled During Manufacturing /Shipping (2912); Improper Flow or Infusion (2954)

Patient Problems Hypervolemia (2664); Insufficient Information (4580)

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer returned a return saline line and return line from a used optia exchange set.Visual inspection confirmed the reported defect.The return saline roller clamp was misassembled onto the return line instead of the return saline line.The return saline roller and pinch clamps were both in the closed position upon receipt of the set.Air was also noted in both the return and return saline lines.In summary, the reported defect was confirmed.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that on the return line, the roller clamp was attached to the blood line, not the saline line.No alarm occurred.Patient information and outcome is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10 (h.11) nvestigation: the customer returned a return saline line and return line from a used optia exchange set.Visual inspection confirmed the reported defect.The return saline roller clamp was misassembled onto the return line instead of the return saline line.The return saline roller and pinch clamps were both in the closed position upon receipt of the set.Air was also noted in both the return and return saline lines.In summary, the reported defect was confirmed.The customer also provided a picture to further aid in the investigation.The picture confirmed that the return saline roller clamp was misassembled onto the return line.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable lot history search indicated there were no other reported occurrence of misassembled return saline roller clamp on this lot worldwide.The final fluid balance could not be ascertained since the customer could not provide additional information which would allow the determination of the final fluid balance with the unintended saline bolus.Investigation is in process.A follow up report will be provided.

Event Description

The customer stated that the return saline roller clamp was misassembled onto the return line.The error was noticed right at the start of the treatment.When the error was noticed, the employee opened the misplaced return saline roller clamp on the return tubing, and clamped the return saline tubing with a tubing clamp.The treatment was carried out without any problem.Due to eu personal data protection laws, the patient information is not available from the customer.

Event Description

The customer stated that the return saline roller clamp was misassembled onto the return line.The error was noticed right at the start of the treatment.When the error was noticed, the employee opened the misplaced return saline roller clamp on the return tubing, and clamped the return saline tubing with a tubing clamp.The treatment was carried out without any problem.Due to eu personal data protection laws, the patient information is not available from the customer.

Manufacturer Narrative

Investigation: the customer returned a return saline line and return line from a used optia exchange set.Visual inspection confirmed the reported defect.The return saline roller clamp was misassembled onto the return line instead of the return saline line.The return saline roller and pinch clamps were both in the closed position upon receipt of the set.Air was also noted in both the return and return saline lines.In summary, the reported defect was confirmed.The customer also provided a picture to further aid in the investigation.The picture confirmed that the return saline roller clamp was misassembled onto the return line.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable lot history search indicated there were no other reported occurrence of misassembled return saline roller clamp on this lot worldwide.The final fluid balance could not be ascertained since the customer could not provide additional information which would allow the determination of the final fluid balance with the unintended saline bolus.Root cause: a root cause assessment was performed for the unintended saline bolus to the patient.Based on the part evaluation, the cause was a manufacturing error in which the blue, return saline roller clamp was assembled on the incorrect fluid line.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 15124584
• MDR Text Key: 304467982
• Report Number: 1722028-2022-00246
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2022

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: 12/02/2023
• Device Model Number: 10220
• Device Catalogue Number: 12220
• Device Lot Number: 2112283130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 03/13/2024; 03/27/2024
• Supplement Dates FDA Received: 03/22/2024; 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2021
• 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