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

Catalog Number 0225028000E

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

The device was discarded.

Event Description

It was reported, during the first blood transfer from the unit to the re-infusion bag, the blood bag from the kit was perforated and leaked blood onto the floor.The patient required a bag of pre-donated blood.The procedure was completed with no delay.

• 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5999830
• MDR Text Key: 56469450
• Report Number: 0001811755-2016-02521
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K970714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2016

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: 15152012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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
• Patient Outcome(s): Other