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

Catalog Number 70500

Device Problems Disconnection (1171); Loss of Power (1475); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Reaction (2414); Sweating (2444)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a chronic inflammatory demyelinating polyneuropathy (cidp)patient was undergoing a therapeutic plasma exchange (tpe) procedure.During the procedure, the patient's blood pressure decreased to 108/65mmhg and the patient's eye suddenly rolled back into his head, his skin appeared rigid and he developed sweating.The rn paused the procedure and contacted the rapid response team.The rapid response team administered a fluid bolus to the patient via iv.The operator stopped and disconnected the patient.The patient is reported in stable condition.The customer declined to provide patient identifier (id).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.Investigation: the disposable set was not available for return.A device history record review was performed and no issues were found that could have been related to the report of the patient reaction.This patient experienced a similar reaction on (b)(6) 2018 documented in mdr 1722028-2018-00115.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged vasovagal reaction include but are not limited to patient disease state and/or patient sensitivity to the procedure.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7487023
• MDR Text Key: 107357531
• Report Number: 1722028-2018-00114
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Catalogue Number: 70500
• Device Lot Number: 08A15253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2017
• 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: 00047 YR
• Patient Weight: 78