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

Model Number 12320

Device Problems Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during a bone marrow processing (bmp) procedure, it was noticed that the normal saline continued to drip at a very fast rate despite the roller clamp being closed.It continued to drip even after the patient was hooked up and collection started.The customer tried reclosing the clamps and roller clamps and the saline continued to drip.They placed a kelly clamp on the saline line for the remainder of the procedure and removed it for rinseback, with no further issues noted during the collection.Per the customer, the patient received approx.400- 500mls of normal saline.Patient weight is not available at this time.No serious harm or adverse event to the patient was reported.The set is not available for return for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in a.4, b.5 and b.6.Investigation: a disposable complaint history search was performed for this lot and found one report of a similar issue on this lot from the same customer.See 1722028-2022-00197.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 bone marrow processing (bmp) procedure, it was noticed that the normal saline continued to drip at a very fast rate despite the roller clamp being closed.It continued to drip even after the patient was hooked up and collection started.The customer tried reclosing the clamps and roller clamps and the saline continued to drip.They placed a kelly clamp on the saline line for the remainder of the procedure and removed it for rinseback, with no further issues noted during the collection.Per the customer, the patient received approx.400- 500mls of normal saline.No serious harm or adverse event to the patient was reported.The set is not available for return for evaluation.

Event Description

The customer reported that during a car t cell collection, it was noticed that the normal saline continued to drip at a very fast rate despite the roller clamp being closed.It continued to drip even after the patient was hooked up and collection started.The customer tried reclosing the clamps and roller clamps and the saline continued to drip.They placed a kelly clamp on the saline line for the remainder of the procedure and removed it for rinseback, with no further issues noted during the collection.Per the customer, the patient received approx.400- 500mls of normal saline.No serious harm or adverse event to the patient was reported.The set is not available for return for evaluation.

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found one report of a similar issue on this lot from the same customer: 1722028-2022-00197.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on the information provided, the specific root cause for the reported failure could not be determined.It is possible the saline roller clamps had not been sufficiently closed, or there was an unidentified disposable manufacturing error.

Event Description

The customer reported that during a bone marrow processing (bmp) procedure, it was noticed that the normal saline continued to drip at a very fast rate despite the roller clamp being closed.It continued to drip even after the patient was hooked up and collection started.The customer tried reclosing the clamps and roller clamps and the saline continued to drip.They placed a kelly clamp on the saline line for the remainder of the procedure and removed it for rinseback, with no further issues noted during the collection.Per the customer, the patient received approx.400- 500mls of normal saline.Patient weight is not available at this time.No serious harm or adverse event to the patient was reported.The set is not available for return for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: a disposable complaint history search was performed for this lot and found one report of a similar issue on this lot from the same customer.See 1722028-2022-00197.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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• 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: 15580799
• MDR Text Key: 306777455
• Report Number: 1722028-2022-00332
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 10/11/2022

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: 12/01/2023
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2112023130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 05/16/2023; 07/19/2023; 07/27/2023
• Supplement Dates FDA Received: 06/08/2023; 07/24/2023; 07/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2021
• 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
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 72 KG