MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC 600ML, 1-7ML/HR SELECT-A-FLOW +1-7ML/HR; ELASTOMERIC PUMP

Model Number CB6007

Device Problems Leak/Splash (1354); Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

Fill volume: 750ml.A pump pre-filler facility initially reported a pump that felt tender and was leaking.Upon evaluation of the returned sample, it was discovered that the pump had a break at the inner latex membrane.The pump was not used on a patient.

Manufacturer Narrative

(b)(4).Method: the device was received for analysis.A visual inspection and a review of the device history record (dhr) were performed.Results: there are no testing results available as the investigation and evaluation are currently in progress.However, the dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.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

Methods: along with the previously reported methods, a microscopic inspection was performed.Results: a visual inspection found the pump returned full.The pinch clamps were opened and each select-a-flow (saf) infused at all selectable flow rates.The bladder did not have the same firmness as normal.The tubing was cut two inches distal to the blue connector in order to drain the medication.The tubing was bonded back together.A scissor was used to cut open the dust cover and a break in the inner latex membrane was visible.The leak was unable to be evaluated.A dremel tool was used to cut the snap caps off of the bladder.A scissor was used to cut away the remainder of the dust cover and the outer latex membrane.A break in the inner membrane was clearly visible after removing the outer latex membrane.The ruptured area was examined under magnification.The latex surface near the rupture had abrasive marks on it.There are areas of the latex membrane at the corners of the rupture where the material appears stretched or torn.Conclusions: the investigation summary concluded that the pump infused at both of the select-a-flow (saf)s for all selectable flow rates.The pump did not have the same firmness as normal.After draining the pump and opening the dust cover a break was observed in the inner latex membrane.Analysis of the membrane shows abrasions near the area of the rupture and stretching in the corners of the rupture.It was reported that the pump with a nominal fill volume of 600ml was filled to the maximum fill volume of 750ml.As previously reported, there was no patient contact and the incident was discovered during the filling process.The process review, which includes visual and functional inspections, indicates that the lot was manufactured according to approved procedures.As previously reported, the lot met the process specifications, including the quality control acceptance criteria prior to release.A quality alert of complaint and training to manufacturing personnel were performed.In addition, as a preventative measure, a scar has been opened and issued to our supplier to investigate this failure.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 SELECT-A-FLOW +1-7ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4772796
• MDR Text Key: 5950195
• Report Number: 2026095-2015-00150
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 04/24/2015

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: Service Personnel
• Device Expiration Date: 02/28/2017
• Device Model Number: CB6007
• Device Catalogue Number: 101347702
• Device Lot Number: 0201578130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2014
• 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