MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO CBCII BLOOD CONSERVATION RESERVOIR ONLY; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225028000

Device Problem Suction Problem (2170)

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

Event Date 05/21/2014

Event Type  malfunction  

Event Description

It was reported that postoperatively the cbcii blood conservation reservoir stopped working.It was reported that the unit collected less than 10 cc of blood, which had to be discarded.It was reported that the patient did not require any additional blood or pre-donated blood and that a backup was used with no affect to the patient.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device will not be returned as it was discarded by the user facility; it is not possible to determine the cause of the reported malfunction without an evaluation of the device.The device was discarded by the user facility.

• Brand Name: CBCII BLOOD CONSERVATION RESERVOIR ONLY
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• 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: 3876496
• MDR Text Key: 4513045
• Report Number: 0001811755-2014-02170
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0225028000
• Device Lot Number: 13322022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2013
• 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