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

Model Number 10310

Device Problems Contamination (1120); Disconnection (1171); No Apparent Adverse Event (3189)

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

Event Date 10/11/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used collect bag was returned to terumo bct for investigation.Visual inspection confirmed the tubing was detached from the bond socket.Minimal solvent is noted on the end of the detached tubing.Additionally, no tubing remnants could be found inside the bond socket indicating a manufacturing bonding error.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that after a allogenic peripheral blood stem cell (pbsc) collection on a patient with myelodysplastic syndrome (mds), the collection port came disconnected in the lab.Some pbsc product was lost and contaminated.The product was sent for aerobic, anaerobic, and gram stain testing.Results are pending; after 24 hours, there was no growth.The customer was able to save 60ml of product, pending the results to determine whether to use the product.The patient is in stable condition and required no medical intervention.The customer declined to provide patient identifier.Donor information: male, (b)(6); donor was not mobilized, but donated again the following day.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Correction: information regarding this failure was communicated with the relevant manufacturing personnel for awareness.

Event Description

The donor was also noted to be stable and donated the subsequent day after the incident but was not mobilized.Donor unit id: (b)(6).

Manufacturer Narrative

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.Negative culture results were confirmed after 14 days aerobic and aerobic bacterial incubation and gram stain was confirmed.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the root cause of the reported leak was a manufacturing error whereby an inadequate quantity of solvent was applied to the collect tubing end when bonding the tubing into the collect bag.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10785360
• MDR Text Key: 216858203
• Report Number: 1722028-2020-00495
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2020

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: 06/01/2022
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Device Lot Number: 2006013130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/25/2020; 11/25/2020
• Supplement Dates FDA Received: 11/26/2020; 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00067 YR
• Patient Weight: 77