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

Catalog Number 000000000000070700

Device Problem Fluid/Blood Leak (1250)

Patient Problems Headache (1880); Pain (1994); Pulmonary Edema (2020); Ventilator Dependent (2395); Blood Loss (2597); Test Result (2695)

Event Date 05/23/2015

Event Type  Injury  

Manufacturer Narrative

Med watch report #: (b)(4) for event codes provided by the user facility in (anemia) - anemia is not specifically addressed in the device labeling.(headache) - headache is listed as a known possible patient reaction during apheresis in the cobe spectra essentials guide- (pain) - pain is not specifically addressed in the device labeling.(ifu issue) ifus are available with each spectra device and can also be obtained on line.Ifus specify which disposable set to use for each procedure being performed.(incorrect product used) - ifus specify which disposable set to use for each procedure being performed.Additional evaluation method code used: sterilization process review investigation: fresh frozen plasma was used as a replacement fluid.3231ml replacement fluid was used, 2677 was removed from the patient, and fluid balance was 554ml.All spectra procedures use a confirmatory screen at the beginning of prime that states what disposable was entered.During run, the procedure type is displayed in the corner of the screen.Also, the data entry screens are different for each type of procedure, making mistakes more obvious.A service call was placed and a full machine checkout was performed.The machine is functioning per manufacturers specification.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the cause, as described by the customer, was an incorrect set used by the operator.Additional information: follow up with the customer was performed.The customer now requires a second associate to confirm and sign thereby stating that the correct kit has been chosen for the procedure.

Event Description

The customer reported that a red blood cell exchange (rbcx) disposable set was inadvertently used for a therapeutic plasma exchange (tpe) procedure.At 20 minutes into the procedure, blood was noticed in the collection bag.The treatment was paused and the attending physician was consulted.The physician stated that it was part of the disease process.The treatment was continued and approximately two hours later, the patient began to complain of a headache and back pain.The procedure was paused and the physician was called.Per physician's order, the procedure was stopped and post complete blood count (cbc) was performed.Test results shown the patient's hemoglobin level was 2.3g/dl.The patient was transfused with four units of packed red blood cells (prbc).The patient went into pulmonary edema and was transferred to icu and was placed a ventilator.The patient received dialysis for fluid removal and was extubated after dialysis.The patient was moved back to a regular room and daily dialysis and apheresis treatments were continued.The patient is reported to be in stable condition.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Corrective and preventive action: an internal capa has been initiated to address user interface issue of using an incorrect disposable set for a procedure.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury in the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA RBCX SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4913417
• MDR Text Key: 22527733
• Report Number: 1722028-2015-00253
• 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,other,use
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 06/19/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Catalogue Number: 000000000000070700
• Device Lot Number: 01W15262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 74