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

Model Number 70105.3824

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A supplemental medwatch will be submitted when additional information becomes available.

Event Description

Upon opening package, customer noticed that oxygenator had a cracked blood inlet port.No patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).The lot #, expiration date and manufacture date were populated.

Event Description

(b)(4).(b)(6).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) received the product back for investigation.During visual inspection a long and deep scratch was noticed on blood inlet connector.The scratch is 2.8 cm long and ran across the whole connector.A tightness test with the original tubes could not be performed as the tubes had been cut to short by the customer.New tubes were fixed on by the laboratory and a tightness test was performed.The reported leakage could be confirmed.The manufacturer`s review of the quality control process indicated that a 100% functional inspection for leakage was conducted during manufacturing.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damage found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.The exact root-cause which led to the described failure could not be identified.A supplemental medwatch will be submitted as soon as additional information becomes available.

Event Description

(b)(4).

• Brand Name: QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5347461
• MDR Text Key: 35608542
• Report Number: 8010762-2016-00004
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Model Number: 70105.3824
• Device Catalogue Number: 701053824
• Device Lot Number: 70104680
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2016; 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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