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

Catalog Number 0225028000

Device Problem Infusion or Flow Problem (2964)

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

Event Date 02/08/2017

Event Type  malfunction  

Event Description

The user facility reported that the red seal failed and the motor was not running.150 ml of blood was collected.The dressing was saturated with blood and came out around the drain hole.Attempts were made to obtain additional information about the event; no further information was received.

Manufacturer Narrative

The product was not found to return.

Event Description

The user facility reported that the red seal failed and the motor was not running.150 ml of blood was collected.The dressing was saturated with blood and came out around the drain hole.The wound needed to be evaluated and the dressing was replaced on the patient.There was no delay, adverse consequences or medical intervention.

Event Description

The user facility reported that the red seal failed and the motor was not running.150 ml of blood was collected.The dressing was saturated with blood and came out around the drain hole.The wound needed to be evaluated and the dressing was replaced on the patient.There was no delay, adverse consequences or medical intervention.

• 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 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: 6521100
• MDR Text Key: 73666531
• Report Number: 0001811755-2017-00885
• 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,Followup,Followup
• Report Date: 06/07/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/06/2017; 06/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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