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

Catalog Number 70500

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Death (1802); Fever (1858); Respiratory Distress (2045); Septic Shock (2068); Malaise (2359); Cognitive Changes (2551); Multiple Organ Failure (3261)

Event Date 01/21/2011

Event Type  Death  

Manufacturer Narrative

Article:lirong qu, kiss, joseph e., dargo, gina, and carcillo, joseph a.(2011).Outcomes of previously healthy pediatric patients with fulminant sepsis-induced multi system organ failure receiving therapeutic plasma exchange.Journal of clinical apheresis, 26, 208-213.Investigation is in progress.A follow-up report will be provided.

Event Description

During a terumo bct review of the journal of clinical apheresis, a report was found of a patient's death later the same day after a therapeutic plasma exchange (tpe).The patient's blood culture was positive at the time of admission for streptococcus pyogenes.The patient developed multi system organ failure associated with a fulminant bacterial infection.The patient had a 3-day history of malaise, a 1-day history of high fever, purpura, agitation, mental status changes, respiratory distress and septic shock.The patient proceeded to cardiac arrest before the institution of the tpe.The patient died later the same day of the tpe treatment.The patient's identifier and weight are not available at this time.The article was sent to journal on 01/21/2011.The disposable set is not available for return, because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in describe event or problem, occupation, evaluation codes and additional mfr narrative.Investigation: the lot number was not provided for this event, therefore, a device history record (dhr) review could not be conducted for this specific device lot number.All lots must meet acceptance criteria for release.This therapeutic plasma exchange (tpe) set was unavailable for return and analysis.The journal article indicates that the tpe procedure was successful.There was no mention of any problems during the procedure.Root cause: the definitive root cause of the patient death could not be determined as the customer could not provide any information about the procedure or the death as she did not have the patient's name.The patient had experienced multi system organ failure that was associated with a fulminant bacterial infection.Per the customer, the tpe procedure was successfully performed around 24 hours after the onset of multi-symptom organ failure (msof).The patient died later the same day.The patient did not die during treatment on the cobe spectra.The procedure was completed with no problems.The information available indicates that the death did not occur during the tpe procedure and the patient had already experienced msof, resulting from bacterial infection,prior to the tpe procedure.Therefore, a possible cause for the patient's death includes but is not limited to the patient¿s disease state.

Event Description

The patient's identifier and weight were not available per the customer.

Manufacturer Narrative

This report is being filed to provide additional information: per the therapeutic apheresis handbook, reactions may occur in as many as 7.8% of plasma exchange procedures.This reference also indicates that morbidity and mortality related to therapeutic procedures are greater in acutely ill patients than in "routine" patients.A patient's death during an apheresis procedure is most often attributed to the underlying disease and is rarely directly related to the procedure.Per the journal article, it indicates that the tpe procedure was successful.There was no mention of any problems during the procedure.The customer could not provide any additional details about the procedure or the death as she did not have the patient name.(lirong et.Al, 2011, pg.210).

Manufacturer Narrative

Additional information: per terumo bct's medical review, the device did not cause or contribute to this incident.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5733674
• MDR Text Key: 47704247
• Report Number: 1722028-2016-00384
• 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: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/17/2016

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: 05/26/2016
• Initial Date FDA Received: 06/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/29/2016; 10/14/2016; 11/07/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00007 YR