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

Catalog Number 10220

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: per the rn at the customer site, 808 mls of patient's plasma was removed and replaced with 757 ml of 5% albumin.During follow-up she confirmed checking the tubing carefully as it was part of her initial training.Per the customer, the biomed at the site performed service on the machine and found no issues.The customer provided a photograph of the used disposable set to terumo bct for evaluation.Upon inspection, it was confirmed that a fluid leak in the centrifuge was apparent as blood was present on the filler.A portion of the upper channel perimeter weld edge was sheared off.The damage was noted to have penetrated through to the vinyl causing a small tear in the channel material and was confirmed as the source of the leak.A witness line present on the channel material was noted and is indicative that the channel was above the filler edge at this location.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 a post kidney transplant patient underwent a therapeutic plasma exchange (tpe) procedure on a spectra optia device.Approximately 30 minutes into the procedure the centrifuge stopped suddenly and a 'fluid detected' alarm occured.The operator clamped the patient line immediately and stopped the procedure.Per the rn, on opening the centrifuge, blood was found inside and upon examining the disposable set, a hole was discovered in the channel.Per physician¿s order, prophylactic antibiotics were administered to the patient intravenously (iv) as a proactive treatment for any possible infection and complete blood count (cbc) and hemoglobin (hb) diagnostic tests were performed that found to have normal levels.Per the customer, the rest of the procedure was completed on another machine without any issues and per physician's order culture tests done were found negative before starting the procedure for second time.The patient stayed at the facility for 3 hours after the completion of the procedure and went home afterwards with the prescribed antibiotic vancomycin (iv)and other oral antibiotics.The customer reported the patient to be in stable condition at home.The tpe set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Correction: machine loading retraining was performed on (b(6) 2019 at the customer site.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: although this event was a user interface issue that caused the leak, thecentrifuge is under positive pressure when spinning.When this leak occurred, the pumps hadstopped and were occluding the tubing therefore the possibility of microbial contamination doesnot exist because nothing is being returned to the patient at this point.Due to the systemspositive pressure for a blood leak in the centrifuge, blood would leak out of the set and not bedrawn into the set/system and not cause harm to the patient.Root cause: based on the images provided, the root cause was determined to be incompleteseating of the channel in the filler.Incomplete seating of a channel will increase the pressure onthe portion of the channel above the filler until it bursts or the channel may come out of the fillerand come into contact with other parts, such as the loop arm, causing physical damage to thechannel.Due to the nature of the design of the product, the method used to load the set is vital toensure the system functions properly.Terumo bct medical review found that the evidence suggest that the cause of this incident wasdue to an incomplete seating of the channel in the filler related to an operator misload use errorwhile performing the procedure.No risk of microbial contamination or air ingress existed with this event since positive pressureduring centrifugation caused blood to leak out of the system without the possibility of blood or airingress to the patient.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8378234
• MDR Text Key: 137421987
• Report Number: 1722028-2019-00040
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K172590
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: 10220
• Device Lot Number: 1812183230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 03/18/2019; 03/26/2019
• Supplement Dates FDA Received: 03/22/2019; 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00015 YR
• Patient Weight: 34