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

Model Number HMO 71000-J

Device Problem Crack (1135)

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

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product has been investigated in the laboratory of the manufacturer with the following results: during tightness test a crack at the connector of the de-airing cock on upper blood outlet side was detected the event report of complaint # (b)(4) was not describing this issue.Our review of the quality control process indicated that a 100% functional inspection for leakage is conducted during manufacturing.This should be adequate to detect products that do not meet the performance specifications prior to release for final packaging and sterilization.As a probable cause for the crack the return transport could be determined.Because the product was only packed in bags within a carton.No biokit was used.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

Investigation results out of complaint (b)(4) (8010762-2015-01054).The product has been investigated in the laboratory of the manufacturer with the following results: during tightness test a crack at the connector of the de-airing cock on upper blood outlet side was detected.Ref.: # (b)(4).

• Brand Name: QUADROX-I ADULT WITH INTEGRATED FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5294691
• MDR Text Key: 34134867
• Report Number: 8010762-2015-01244
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Model Number: HMO 71000-J
• Device Catalogue Number: 70104.8762
• Device Lot Number: 70103788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1