MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-07-20 for TRUCHOICE 213-030NS manufactured by Alliant Healthcare Products.
[2360188]
This notification has been initiated due to two reported product malfunctions with the 3-t l. V. Control valve, 510(k) # (b)(4), a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the build-up of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air into the heart. In both occurrences, the device came apart at the glue joint that holds the two halves together. In one of the two occurrences, the one-way duckbill valve fell out. Both malfunctions occurred in routine setup prior to the product being taken into the operating room. The malfunctions did not involve any pts and no delays in any surgeries were reported. In the unlikely event that the product's vent valve used for left ventricular venting malfunctions at the time the aortic clamp is removed, perfusion flow could be disrupted possibly causing injury to the pt. Both devices were reported to be from the same lot of 200 pieces. The second malfunction was confirmed; the device related to the first reported malfunction was not returned and could not be confirmed.
Patient Sequence No: 1, Text Type: D, B5
[9384772]
The company's initial investigation of the actual device that caused the complaint indicates that the glue bond was not sufficient. Prior to (b)(4) 2011, there have been no other reported product malfunctions since the company started producing the product 5 years ago. The company has produced approx (b)(4) vent valve devices during the same period. The company has taken the follow actions: immediately upon notification of the complaint on (b)(4), the company formed a review team to investigate the health risk to pts and root cause. The company's investigation is on-going and no definitive root cause has been identified. There is no specific info that leads to any final conclusion at this time. Corrective and preventive actions are being initiated as info develops. The company has currently ceased distribution and mfg of the product. The company is developing a recall plan that will protect pts and that also considers the importance of not delaying necessary and critical surgeries. The company has sufficient stock of a substitute product to send sterile replacements to the hospitals. This substitute product offers a one-way vent valve and is ultrasonically welded and does not use a similar glue joint as found in the recalled product. This particular design does not offer an adjustable control knob, and that feature will not be available with the substitute product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004986960-2011-00001 |
| MDR Report Key | 2329957 |
| Report Source | 08 |
| Date Received | 2011-07-20 |
| Date of Report | 2011-07-19 |
| Date Mfgr Received | 2011-06-21 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2012-06-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | REBECCA HUDSON |
| Manufacturer Street | 8850 M-89 |
| Manufacturer City | RICHLAND MI 49083 |
| Manufacturer Country | US |
| Manufacturer Postal | 49083 |
| Manufacturer Phone | 2696290300 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUCHOICE |
| Generic Name | ADJUSTABLE VENT VALVE |
| Product Code | MJJ |
| Date Received | 2011-07-20 |
| Returned To Mfg | 2011-07-06 |
| Model Number | 213-030NS |
| Catalog Number | 213-030NS |
| Lot Number | 2010-09-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLIANT HEALTHCARE PRODUCTS |
| Manufacturer Address | RICHLAND MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-20 |