MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CBCII(NO DRN)PKG/6 W/CAPACITOR; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225028000E

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2014

Event Type  Injury  

Event Description

It was reported that at the user facility, clots formed, preventing transfusion of collected autologous blood from the device to a bag.The patient could not receive this blood and was administered two doses of blood from another source.

Manufacturer Narrative

The device was not returned for analysis.

• Brand Name: CBCII(NO DRN)PKG/6 W/CAPACITOR
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4205649
• MDR Text Key: 18870526
• Report Number: 0001811755-2014-03780
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K952224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/03/2014

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 Catalogue Number: 0225028000E
• Device Lot Number: 14173012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2014
• 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): Required Intervention