MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC WOUND DRAIN; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225426000

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 10/28/2014

Event Type  Injury  

Event Description

It was reported that following a surgical procedure at the user facility, clotted blood was evident in the reservoir.Therefore, the blood collected by the device could not be transfused.The patient was given an autotransfusion using spare blood.No procedural delay or adverse consequences were reported with this event.

Manufacturer Narrative

The device was not returned for analysis; it is not possible to perform a device evaluation without return of the device.

• Brand Name: CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC WOUND DRAIN
• 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: 4257608
• MDR Text Key: 16992457
• Report Number: 0001811755-2014-04146
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K952224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2014

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: 0225426000
• Device Lot Number: 14219012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2014
• 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