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

Catalog Number	0225028000E
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded.
Event or Problem 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
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• MDR Report Key: 7784412
• Report Number: 0001811755-2018-01587
• Device Sequence Number: 19348232
• Product Code: CAC
• UDI-Device Identifier: 34546540867132
• UDI-Public: 34546540867132
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K970714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 0225028000E
• Device Lot Number: 15126012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1