MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA TPE SET

Catalog Number 000000000000070500

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Micturition Urgency (1871); Overdose (1988)

Event Date 02/28/2014

Event Type  malfunction  

Event Description

The customer reported that 45 minutes into a plasma exchange procedure, he noticed the remove bag didn't have as much plasma in it as was expected.Per the customer, they had given approximately 2 liters in replacement fluid, but it didn't seem like there was as much removed plasma in the remove bag.The patient also said he needed to void very badly.The customer stated he saw an air bubble in the plasma line and tried to get it out, and did a couple of times, but it came back.After trying to troubleshoot for a while, he decided to rinse back the patient.He then reloaded the same machine with new tubing and fluids, and continued the procedure without any further problems.Per the customer, they believe the patient received approximately 800mls extra fluid.No medical intervention was necessary for this event, and the patient is in stable condition.The customer declined to provide the patient identifier.The disposable set is not available for return for evaluation because the customer discarded it.This report is being filed due to insufficient information at this time to determine if a malfunction with the potential for injury occurred.

Manufacturer Narrative

Investigation evaluation and corrective actions are in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: 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.A review of the lot for similar reports was carried out, none have been reported.Root cause: this disposable set was unavailable for specific root cause analysis.A definitive root cause could not be determined.Possible causes for the hypervolemia and visual air bubble include but are not limited to misassembly of the disposable set, occlusion in the disposable set, misload in of the disposable set, or improper clamping during the procedure.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which anevent occurred, but the type of reportable event was not indicated appropriately.This supplement is being filed to modify information to align with the reported event.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: kristen cohen ; 10811 w collins avenue; lakewood, CO 80215 ; 3032052870
• MDR Report Key: 3706336
• MDR Text Key: 20299053
• Report Number: 1722028-2014-00099
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080035
• 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,Followup
• Report Date: 02/28/2014

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: 01/01/2016
• Device Catalogue Number: 000000000000070500
• Device Lot Number: 01V15261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 03/27/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/23/2014; 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2013
• 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 Age: 00077 YR
• Patient Weight: 81