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

Catalog Number 000000000000010220

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 02/02/2015

Event Type  Injury  

Event Description

The customer reported that a patient underwent a therapeutic plasma exchange (tpe)procedure.Post procedure, the rn was removing the return line from the patient's tunneled central catheter and noticed the tip of the return line connected to the patient's access line broke off.Per physician's order, an x-ray guided replacement central line was needed and antibotics via iv were given to the patient.The patient is reported in stable condition.The customer declined to provide the patient identifier.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per the customer, the return line was difficult to twist off and that they had to apply some pressure.During customer follow-up, the customer stated that they were able to remove the tip from the line and the replacement central line was no longer needed.The disposable set was unavailable for return and investigation.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: this disposable set was unavailable for specific root cause analysis.A definitive rootcause could not be determined.Possible causes for the broken luer include cross-threaded luer connection between the return line luer and the catheter or a defective luer component.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs, per fda request, to identifyrecords in which a serious injury or medical intervention occurred, but the type of reportableevent was not indicated as a serious injury.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4554869
• MDR Text Key: 5478143
• Report Number: 1722028-2015-00062
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 01Y3108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2015
• 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): Required Intervention
• Patient Age: 00018 YR
• Patient Weight: 52