MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BY-PASS

Model Number 70105.0758

Device Problem Break (1069)

Patient Problem Cardiac Arrest (1762)

Event Date 01/16/2012

Event Type  Injury  

Event Description

On (b)(6) 2012, at (b)(6), the arterial connector came off the quadrox i be-01970311-pls d oxygenator (lot number 70064784) during a ecmo procedure after the unit was accidentally bumped.As the pump ran at 5 l/min, a significant amount of blood was lost, even though the constriction of the hoses was rapid.The patient went into cardiac arrest and was depressurized until the blood was infused and the heart massage could work.After about 15 minutes, there was a new set of pls primed up and started without problems.(b)(4).

Manufacturer Narrative

(b)(4).The customer reported this event to the (b)(6).The returned sample was analyzed in the laboratory.A visual inspection determined that the connector of the blood outlet had fallen off.During the evaluation it was determined that the connector was fully glued into a groove.The distribution as well as the amount of the glue made a well impression.It was determined that a possible reason for this event is when the user accidently bumped the unit.Note: the reported event occurred when using the be-01970311-pls d quadrox-i oxygenator, however a equivalent device marketed in the us is used for reporting.(b)(4).

• Brand Name: QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BY-PASS
• Manufacturer (Section D): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4282953
• MDR Text Key: 5226575
• Report Number: 8010762-2014-01139
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: 70105.0758
• Device Catalogue Number: BE-01970311-PLS D
• Device Lot Number: 70064784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2012
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2012
• Initial Date Manufacturer Received: 01/17/2012
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2011
• 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): Required Intervention