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

Catalog Number 12120

Device Problems Misassembled (1398); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.Correction: manufacturing staff were made aware of this issue and retrained to the appropriate procedures.

Event Description

The customer reported that during a spectra optia mononuclear cell (mnc) collection the return clamp was assembled on the return line instead of the return saline line.The machine alerted return pressure alarms.Per the customer, no injury occurred, and no medical intervention was required.Due to eu personal data protection laws, the patient information is not available from the customer.The spectra optia collection set is not available because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the customer did return a used optia collect set for investigation.Visual inspection confirmed the presence of blood throughout the set, including the return line.The reported defect was identified via a misassembled roller clamp.The saline return line roller clamp (blue) was verified on the return line.The run data file (rdf) analysis was analyzed for this event.Per the rdf, total fluids removed/collected (displayed): 21ml (ac 2).Total amount of fluids machine gave (displayed): 194ml.Per the customer, a 500 ml saline bag was hooked up but only about half a bag of volume was used.The patient's adjusted final fluid balance is determined to be 111.2 %.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the mis-assembly of this set.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.Investigation is in process.A follow-up report will be provided.

Event Description

Patient gender and weight were obtained from the run data file (rdf).

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: the cause of the roller clamp defect was related to a misassembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.Correction: manufacturing staff were made aware of this issue and retrained to the appropriate procedures.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECTION SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7876984
• MDR Text Key: 120705047
• Report Number: 1722028-2018-00254
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2018

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: 04/01/2020
• Device Catalogue Number: 12120
• Device Lot Number: 1804103330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 10/24/2018; 11/02/2018
• Supplement Dates FDA Received: 11/02/2018; 11/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• 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 Weight: 70