MAUDE Adverse Event Report: ZIMMER SURGICAL HEMOVAC AUTOTRANSFUSION SYSTEM, 3/16 IN SOF

Catalog Number 00-2555-030-05

Device Problems Leak/Splash (1354); Decrease in Pressure (1490); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2015

Event Type  malfunction  

Event Description

It was reported that during surgery, there was blood leaking from the line, so the zimmer hemovac was used with a plastic bag in order to prevent leaking.There was also reported low negative pressure.The device was reported to be from the same lot number and be leaking in the same location as a previously reported device.The issue was discovered after surgery and there was no direct skin or mucous membrane contact with the patient or the healthcare staff, and the healthcare staff member was wearing gloves when handling the device.There was no patient or user harm associated with the report.No additional clinical info was received prior to this report.

Manufacturer Narrative

The reported device was discarded by the hosp and was not returned for evaluation.The reported event cannot be confirmed or root cause determined without the returned device.The dhr was reviewed with no noted issues or relevant nonconformances for this manufacturing lot.The manufacturing and inspection process for the has kit was reviewed.All of the procedures used in the production of this device was mature and approved.No systemic concerns or issues were identified in the review of these procedures.The incoming inspection of the resenex connectors reported no issues or nonconformances.Historically, the cause for incidents similar to this report is due to the two connectors not being coupled.If the male and female connectors are not fully engaged than an air leak can occur causing a possibility of small leak at that joint as well as weaker vacuum pressure.There are too many variables to allow determining the true cause for the connectors not being correctly connected.Most likely, the connects were accidently uncoupled by the patient moving in the bed and not reconnected completely.

• Brand Name: HEMOVAC AUTOTRANSFUSION SYSTEM, 3/16 IN SOF
• Type of Device: HEMOVAC AUTOTRANSFUSION SYSTEM, 3/16 IN SOF
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 4564241
• MDR Text Key: 5560379
• Report Number: 1526350-2015-00045
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2015
• Device Catalogue Number: 00-2555-030-05
• Device Lot Number: 62180280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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