MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number H 23944

Device Problems Fluid/Blood Leak (1250); Occlusion Within Device (1423); Device Dislodged or Dislocated (2923)

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

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for evaluation yet.Maquet cardiopulmonary (b)(4) will submit a supplemental medwatch on receipt of further information.

Event Description

According to the hospital: "blood leaking has observed at head line of the pump.The line was dislodged and slit was observed.The occlusion of pump was set before operation, so there was no problem related with this.It has also reported that there was no kink or clamp on the lines.The set has changed and the surgery has continued with no problem.The questioned product has been returned for investigation." (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) received the product for investigation.Visual control was performed in the laboratory of manufacturer.Pvc 3/8 x 1/16 tube has damages in three places.It can be recognized by the pinch marks of the tube that the tube has burst due to the pressure rollers of the pump.No further abnormalities noted.Trend search was performed: 0 additional complaint were recorded which reported issues are the same since the last 12 months.Dhr was reviewed.A rework record was found for reason 'damaged box' and quantity 2.No any other abnormality was found.Based on the sales figures of the last 12 month following occurrence rate has been calculated: (b)(4)%, which is below 1%.Due to this, no systemic issue could be determined.The available information has been shared internally with getinge therapy application manager.It was stated as: "possible causes for this incident or promoting effects are, but may not limited to:i.Over-occlusion of the corresponding arterial roller pump device hence inadequate occlusion adjustment prior to operation or procedure ii.Inappropriate tubing fixation, such as tubing guide inserts with incorrect dimensions, e.G.1/2" tubing guide inserts for 3/8¿ dimension iii.Inappropriate tubing fixation due to unlocked tubing fixation latch iv.Un-passable guide roller(s) of the corresponding roller pump v.Debris inside the roller head raceway vi.Kink(s) in the corresponding tube as an out of the box issue vii.Bending of the tube or improperly insertion, e.G.Twisted or under tension" according to the investigation results and clinical evaluation, the most probable cause of the failure could be user error.Based on these, complaint could not be confirmed.

Event Description

(b)(4).

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• 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: 7059782
• MDR Text Key: 93710115
• Report Number: 8010762-2017-00371
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K053025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2018
• Device Model Number: H 23944
• Device Catalogue Number: 701050650
• Device Lot Number: 9221614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2018
• Date Device Manufactured: 12/01/2016
• 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