MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I- OXYGENATOR; MICROPOROSE MEMBRANE OXYGENATOR

Catalog Number 70105.0758

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problems Death (1802); Rupture (2208)

Event Date 05/22/2014

Event Type  Death  

Event Description

It was reported that blood was found dripping from the gas outlet after approx one hour of use.Device change out was prepared but not accomplished.Pt was too unstable.Ventricular rupture was suspected.Therapy was terminated.Pt expired under resuscitation conditions.Add'l info received on (b)(6) 2014: "blood flow (total): 3.68 1/min, rotation: 4144/min, gas flow: 2.0 1/min, fio2: 1.0%, no arterial deposits, act (anti coagulation time) 220.(b)(4).

Manufacturer Narrative

(b)(4).Maquet is aware of similar complaints.The devices displayed a similar malfunction which was tested and evaluated under na optical microscope.Delamination of some gas fibers was observed which allowed for the priming solution or blood to flow inside the gap between the gas fibers and polyurethane.Gravity then allowed for passage to the gas exiting path along the housing.The most probable root-cause is the delamination of the hollow gas fibers from the polyurethane potting area.Maquet has initiated an internal process (capa-(b)(4)) to address the appropriate corrective and preventive action.

• Brand Name: QUADROX-I- OXYGENATOR
• Type of Device: MICROPOROSE MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3924997
• MDR Text Key: 4668416
• Report Number: 8010762-2014-00239
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2014,05/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Catalogue Number: 70105.0758
• Device Lot Number: 70098206
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/17/2014
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 65