MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC 600ML, 1-7ML/HR SAF #1-7ML/HR; ELASTOMERIC PUMP

Model Number CB60007

Device Problems Split (2537); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2015

Event Type  malfunction  

Event Description

It was initially reported that the pump was leaking around the bottom white band (snap cap) after the pump was filled.Upon evaluation a rupture of the internal latex membrane was discovered during the sample evaluation.The pump was not used on a patient.

Manufacturer Narrative

Method: the device was received for analysis.A visual inspection was performed and a review of the device history record (dhr) is currently in progress.Results: there are no testing results available as the investigation and evaluation are currently in progress.Conclusions: once the analysis and investigation are completed a follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

Manufacturer Narrative

Method: as previously reported, a microscopic inspection was performed.Results: a visual inspection found the pump returned full.The pinch clamps were opened and the pump infused at both distal luers for all selectable flow rates.During handling the pump did not feel as firm to touch.The tubing was cut 2 inches distal to the blue connector (short male luer adapter) to drain the medication and bonded back together.The pump was refilled to 30ml and no leaks were observed.The pump was refilled with 5ml of food grade dye using a 5cc syringe and a break in the inner bladder was observed.Scissors were used to remove the dust cover for better visualization.The luer connection below the blue connector was opened to drain the pump.Scissors were used to remove the outer latex membrane.The snap caps were removed.The rupture was observed under magnification.The outer latex membrane had signs of attenuation along the length of the split, with filamentous strands originating from the edge of the latex.Attenuation was also observed in the corners of the split on the latex membrane.Small areas of the latex and kraton layer had irregularities on the surface.The device history record (dhr) was reviewed for the lot number of the manufactured unit.The lot met the process specifications, including the quality control acceptance criteria prior to release.The process review, which includes visual and functional inspections, indicates that the lot was manufactured according to approved procedures.Conclusions: the investigation summary for the pump concluded that a break was present on the kraton and inner latex membrane.Infusion verification was performed and the pump infused at all selectable flow rates.During infusion verification the pump did not have the same firmness as the other pumps when filled.A leak test was performed and after refilling the pump with 5ml of food grade dye a break was observed in the bladder.Destructive analysis was performed and found the kraton and inner latex membranes were broken.The outer latex layer was intact.Analysis of the latex membrane found signs of attenuation.However, no root cause was identified.As previously reported, there was no patient contact and the incident was discovered during the filling process.In addition, as a preventative measure, a scar has been opened and issued to our supplier to investigate this failure.An historical review indicated that no other complaints were reported for this reported incident and related to the same lot number.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: ON-Q C-BLOC 600ML, 1-7ML/HR SAF #1-7ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD - IRVINE; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4602539
• MDR Text Key: 5468127
• Report Number: 2026095-2015-00096
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: CB60007
• Device Catalogue Number: 101347702
• Device Lot Number: 0201320364
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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