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

Catalog Number 0225028000E

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device was discarded.

Event Description

The user facility reported that the device collected 500ml of blood and could not be re-infused back to the patient during a procedure.There was no delay, no medical intervention, and no adverse consequences.

• Brand Name: CBCII(NO DRN)PKG/6 W/CAPACITOR
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7784412
• MDR Text Key: 117143803
• Report Number: 0001811755-2018-01587
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 34546540867132
• UDI-Public: 34546540867132
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K970714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2018

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: 0225028000E
• Device Lot Number: 15126012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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