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

Catalog Number 70500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); No Information (3190)

Event Date 06/03/2017

Event Type  Injury  

Manufacturer Narrative

Lot number, expiry and manufacture date are not available at this time.Investigation: per the customer, hypotension occured in spite of ordering 110% fluid balance,100% albumin, up to 20 ml of iv cacl2 and inlet speed not exceeding 80.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paraesthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that near the end of a therapeutic plasma exchange (tpe) procedure,a patient experienced hypotension and complained of nausea.The procedure was paused and the patient was given a saline bolus via iv, and was re-positioned.The customer declined to provide patient outcome.The cobe spectra 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: during follow-up, the customer stated that per the customer¿s site standard operating procedures, the patient's blood pressure was checked every 15 minutes.They typically use 75% (5%albumin) and 25% normal saline (ns) replacement and alternate between the two in roughly even volumes starting with ns, ending with albumin.The customer also stated that they do not believe that there is a correlation between the symptoms the patient experienced and the replacement fluid.The customer's investigation did not yield any unusual results and there have been no additional incidents.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypotension and nausea associated with apheresis are usually well tolerated.The following progression is often observed: pallor and sweating begin, with the skin turning cold, the pulse slows strikingly, the blood pressure decreases and nausea.The run data file (rdf) was analyzed for this event.Rdf analysis confirmed that there was nothing unusual noted in the rdf about the procedural run.The rdf analysis confirmed that spectra optia system operated as intended.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged reactions include but are not limited to the patient's physiology, the patient's disease state, and/or patient sensitivity to the procedure.

Manufacturer Narrative

This report is being filed to provide corrected information.Corrected information: no rdf analysis was performed for this event.

• 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 ; 3032392246
• MDR Report Key: 6689729
• MDR Text Key: 79239093
• Report Number: 1722028-2017-00286
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020041
• 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,Followup
• Report Date: 07/06/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 70500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 07/12/2017; 07/31/2017
• Supplement Dates FDA Received: 07/28/2017; 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 54 YR
• Patient Weight: 98