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

Model Number 10310

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Pain (1994)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that as of (b)(6) 2020, following a stem cell apheresis donation on (b)(6) 2020, the multiple time donor reported experiencing pain at the puncture site and progressive shortness of breath, especially under stress.It is unknown at this time if medical intervention was required for this event.Patient weight and outcome are not available at this time.Terumo bct is awaiting return of the disposable set.

Manufacturer Narrative

This report is being filed to provide additional information in a.4, b.5 and e.1.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that medical intervention was required as the patient had a bilateral pulmonary embolism.Type of medical intervention is unknown at this time.

Manufacturer Narrative

This report is being filed to provide additional information in h10 investigation: according to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors.Only one case of thrombosis has been reported in the literature.Symptoms include pain; antecubital fossa tenderness; swelling of the arm; and a prominent, palpable, cord-like thickening of the thrombosed vein.Medical referral of donors who are experiencing deep vein thrombosis should not be delayed, so that treatment with anticoagulant can begin promptly.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, b.6, h.6 and h.10.Corrected information is provided in d.4, d.9 and h.10.Investigation: per the customer, the incident was due to human error, the optia device did not cause or contribute to the reported incident.The physician declined to provide any additional information regarding both the incident and the human error.The run data file was analyzed for this event.No definitive root cause for the reported adverse events could be identified from the dlog associated with this procedure.The system operated as intended and the procedure was run within standard operating limits (i.E.Not in ¿caution status¿).There were 80 ¿inlet pressure was too low¿ alarms in the procedure.673ml of ac was delivered to the patient over the course of the procedure.Access alarms alone are not known to cause adverse events but the excessive occurrence of them points toward issues with the patient access.The most common source of inlet pressure alarms is when the inlet flow rate is set too high for the given patient access, the patient access is occluded/blocked, or the patient access is not properly positioned.In response to inlet pressure alarms, it is suggested to ensure the patient access is appropriately sized and positioned, nothing is blocking the access line, and to lower the inlet flow rate.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: based on the statement provided by the customer, it was verified there was no device malfunction that caused or contributed to the reported incident.Correction: retraining was not offered to the customer since they declined to disclose any additional information regarding the human error and declined to be contacted further.Corrected investigation: the statement "according to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors.Only one case of thrombosis has been reported in the literature.Symptoms include pain; antecubital fossa tenderness; swelling of the arm; and a prominent, palpable, cord-like thickening of the thrombosed vein.Medical referral of donors who are experiencing deep vein thrombosis should not be delayed, so that treatment with anticoagulant can begin promptly." is no longer applicable to this investigation.

Event Description

The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10460571
• MDR Text Key: 206182924
• Report Number: 1722028-2020-00414
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• 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,Followup,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10310
• Device Catalogue Number: 12320
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 76