MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID ADULT DIFFUSION MEMBRANE OXY.; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-01971311

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 at the medical center (b)(6) it was reported that the gas inlet connector on the quadrox-i be 01971311 oxygenator from lot number 70095640 was broken/disconnected.This was discovered during priming.There are 3 units reported to have this issue in this complaint.The other two will be filed in separate medwatches.Reference mfr's# 8010762-2015-00613 and 8010762-2015-00614.(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The returned sample was inspected visually and it was confirmed that the gas inlet connector was detached from the oxygenator.An on-going investigation for this issue of loose/detached connectors has determined that the detachment is caused due to the debonding of the adhesive from the polycarbonate surface.(b)(4).

• Brand Name: QUADROX-ID ADULT DIFFUSION MEMBRANE OXY.
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4944816
• MDR Text Key: 22157221
• Report Number: 8010762-2015-00484
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2014
• Device Model Number: BE-01971311
• Device Catalogue Number: 70104.1187
• Device Lot Number: 70095640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2014
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2014
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2013
• 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