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 (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 8010762-2015-00484.Reference complaint (b)(4).

Manufacturer Narrative

(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.Reference complaint (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: 4944819
• MDR Text Key: 19987788
• Report Number: 8010762-2015-00614
• 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

• 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: 70095642
• 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
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 07/28/2015
• 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