MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HQV 15301

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received but not yet evaluated.Additional information related to the event has been requested but not received.A follow-up medwatch will be submitted when additional information becomes available.Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-i which is registered under 510(k): k082117.

Event Description

At hlm start, venous air block, volume shortage in system, cracking of the de-airing valve on venous side (yellow plug), hlm stop, replacement of oxygenator.Patient is doing well and on normal station.(b)(4).

Manufacturer Narrative

The product was visually inspected in the complaints laboratory of the manufacturer on 2016-09-23.The yellow cap of the de-airing valve was not present.The de-airing membrane was damaged.During flushing of the blood-side of the oxygenator, a clear leakage from the de-airing membrane was established.Therefore, the customer's reported issue could be confirmed.The damaged membrane was inspected more closely under the microscope, and it was found that the white teflon layer was ruptured but the fleece layer was still intact.The issue was investigated further by r&d and the therapy application/clinical risk manager, and it was concluded that the membrane de-airing membrane had been subjected to abnormally high pressures in the opposite direction to the expected flow.In other words, it was concluded that the pressure must have come from something attached to the de-airing valve connector, or, alternatively, that the membrane was physically damaged from an external source (e.G.A needle).The oxygenator was returned to the complaint laboratory for further testing.A cap was placed on the de-airing valve connector to seal the valve, and the oxygenator was tested again for leaks other than from the de-airing valve and none were found.As a last step, the oxygenator was sawn open to be able to examine the de-airing membrane more closely, and it was concluded that it showed signs of damage from excessive pressure or force, and this reinforces the earlier conclusions that this was user caused.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET W/SOFTLINE COATING
• 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 ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5611654
• MDR Text Key: 44496727
• Report Number: 8010762-2016-00293
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HQV 15301
• Device Catalogue Number: 701027640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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