MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I ADULT OHNE FILTER; CARDIOPULMONARY BYPASS OXYGENATOR

Model Number HMO 70000-J

Device Problem Filtration Problem (2941)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2014

Event Type  malfunction  

Event Description

During use (ecc) on the patient, while the customer was conducting weaning, pressure of the product increased rapidly.(flow rate of the pump: about 2l/min, gas flow rate: about 1l/min, act: more than 700).Inlet blood pressure to the product was monitored by cardiapress (*1).The customer set the upper limit of the blood pressure value of cardiapress about 500 mmhg, but no one heard the alarm generated from cardiapress.And me could not check the displayed value of the blood pressure.Outlet blood pressure from the product was monitored by the pump which was connected to the barrier kit (*2).The upper limit of the pump was set on 300mmhg.The customer noticed the pressure increase because the pump generated alarm sound.The customer confirmed that no kink with the blood transmission cannula.The customer completed weaning.No patient injury was reported.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Maquet cp ag has received the device for evaluation.Investigation is still pending.A supplemental medwatch will be submitted when additional info becomes available.(*1) cardiapress is name of device which is manufactured by (b)(4) company, jms.Caridapress is used to measure the internal pressure of the circuit.(*2) "barrier kit" is also used to measure the internal pressure of the circuit.

• Brand Name: QUADROX-I ADULT OHNE FILTER
• Type of Device: CARDIOPULMONARY BYPASS OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strabe 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 4134646
• MDR Text Key: 4792978
• Report Number: 8010762-2014-00759
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: HMO 70000-J
• Device Catalogue Number: 70104.8759
• Device Lot Number: 70096883
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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