MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HMO 71000-J#QUADROX-1 ADULT + FILTER; MICROPOROUS MEMBRANE OXYGENATOR

Model Number 70104.8762

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

Patient Problem Not Applicable (3189)

Event Date 02/02/2015

Event Type  malfunction  

Event Description

It was reported that blood leakage on the dialysis lock and valve were detected just after initiating cardiac assistance.Blood loss for 5 to 10 minutes was observed but the total amount of blood lost is unk.The decision was made to continue using the device judging from the amount lost blood.The procedure was completed without replacing the product.No reported pt effect.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary is aware of similar complaints for this product.An internal process to investigate the root-cause for this failure has been initiated (capa (b)(4)).Mfr's review of the production process has shown that a 100% final inspection for leakage is performed before the products are released for distribution.Additional info: the product mentioned under section d is not distributed to the us, but the product with contributing design function to the affected component (quadrox-i) is registered under 510 (k): k082117.

• Brand Name: HMO 71000-J#QUADROX-1 ADULT + FILTER
• Type of Device: MICROPOROUS MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4580239
• MDR Text Key: 21174652
• Report Number: 8010762-2015-00100
• 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: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: 70104.8762
• Device Lot Number: 70098506
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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