MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA RED BLOOD CELL EXCHANGE SET

Catalog Number 70700

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Fever (1858); Nausea (1970); Vomiting (2144)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

Investigation: the customer stated that the patient received hydration after the procedure by the hospital staff.Per the customer, the hospital and mobile apheresis are both investigating this incident.The disposable set was unavailable for return.Upon literature review, species moraxella osloensis is a gram (b)(6) bacteria and has been found in hospitals.Per the customer, there were two incidents of line contamination at this hospital associated with this lot.The other incident has been reported on mdr # 1722028-2016-00148.There are no other similar reports associated with this lot#.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the hospital to which they provide apheresis units had a patient with a line infection (right subclavian, dual lumen, vertex port) by a bacteria, moraxella osloensis is.The patient underwent a red blood cell exchange (rbcx) procedure with six units of packed rbcs.The units were associated with lot # 08y15237.Approximately 24 hours post red blood cell exchange (rbcx) procedure, the patient developed a fever, felt nauseated then vomited.Per physician's order, the patient was admitted to the emergency room (er).The patient is reported in stable condition.The customer declined to provide patient identifier and weight.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: a review of the device history record for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in progress.A follow-up report will be provided.

Manufacturer Narrative

Investigation: upon literature review, the genus moraxella consists of aerobic,oxidase-positive, and gram-negative coccobacilli.Moraxella osloensis has been isolated from environmental sources in hospitals and from the normal human respiratory tract and has been reported as a rare causative pathogen of infections in humans.Morazella osloensis is a rare causative organism of infections in humans, with most cases reported in cancer patients.The devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA RED BLOOD CELL EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5529353
• MDR Text Key: 41268921
• Report Number: 1722028-2016-00147
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 70700
• Device Lot Number: 08Y15237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2015
• 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; Required Intervention
• Patient Age: 00010 YR
• Patient Weight: 21