MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO CBCII BLOOD CONSERVATION KIT W/3/16 ROUND PVC DRAIN; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225028626

Device Problem Infusion or Flow Problem (2964)

Patient Problem Blood Loss (2597)

Event Date 03/08/2017

Event Type  Injury  

Event Description

The user facility reported that the device's vacuum did not work well during a procedure.An unknown amount of blood was collected.The patient did require additional blood.

Manufacturer Narrative

The event was not confirmed.Known root causes for this condition can be associated to: mechanical/vacuum failures produced by the assembly process, device damage during usage or during the shipping and handling process.

Event Description

The user facility reported that the device's vacuum did not work well during a procedure.An unknown amount of blood was collected.The patient required additional blood.

Manufacturer Narrative

Product was not available for return.

Event Description

The user facility reported that the device's vacuum did not work well during a procedure.An unknown amount of blood was collected.The patient required additional blood.

• Brand Name: CBCII BLOOD CONSERVATION KIT W/3/16 ROUND PVC DRAIN
• 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: 6440288
• MDR Text Key: 71092564
• Report Number: 0001811755-2017-00813
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K970714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2017

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: 0225028626
• Device Lot Number: 16126012
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: Not provided; 05/22/2017
• Supplement Dates FDA Received: 05/24/2017; 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2016
• 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